RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>70954-977-50</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70954-977-50) </PackageDescription>
    <NDC11Code>70954-0977-50</NDC11Code>
    <ProductNDC>70954-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213676</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:       : 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-977-20</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (70954-977-20) </PackageDescription>
    <NDC11Code>70954-0977-20</NDC11Code>
    <ProductNDC>70954-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213676</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:       : 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-977-30</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (70954-977-30) </PackageDescription>
    <NDC11Code>70954-0977-30</NDC11Code>
    <ProductNDC>70954-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213676</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>97; 103</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:       : 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>10812-977-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10812-977-02)  &gt; 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>10812-0977-02</NDC11Code>
    <ProductNDC>10812-977</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Neutrogena Visibly Even Bb</ProprietaryName>
    <ProprietaryNameSuffix>Broad Spectrum Spf 30 Fair To Light</ProprietaryNameSuffix>
    <NonProprietaryName>Homosalate, Octinoxate, Octisalate, And Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20131015</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Johnson &amp; Johnson Consumer Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>50; 75; 50; 20</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131015</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>16714-977-20</NDCCode>
    <PackageDescription>20 VIAL in 1 CARTON (16714-977-20)  / 50 mL in 1 VIAL (16714-977-01) </PackageDescription>
    <NDC11Code>16714-0977-20</NDC11Code>
    <ProductNDC>16714-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Propofol</ProprietaryName>
    <NonProprietaryName>Propofol</NonProprietaryName>
    <DosageFormName>INJECTION, EMULSION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206408</ApplicationNumber>
    <LabelerName>NorthStar Rx LLC</LabelerName>
    <SubstanceName>PROPOFOL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.</IndicationAndUsage>
    <Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white  homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-977-50</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42291-977-50) </PackageDescription>
    <NDC11Code>42291-0977-50</NDC11Code>
    <ProductNDC>42291-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250827</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078707</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250827</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia ( 1.1) , 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2) , 3 Treatment of irritability associated with autistic disorder ( 1.3) .</IndicationAndUsage>
    <Description>Risperidone Tablets, USP contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl] ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 2and its molecular weight is 410.49. The structural formula is:. Risperidone is a white or almost white powder. It is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol. It dissolves in dilute acid solutions. Risperidone Tablets, USP are available in 0.25 mg (dark yellow), 0.5 mg (Reddish brown), 1 mg (white) strengths, 2 mg (pink), 3 mg (yellow) and 4 mg (green) strengths. Each tablet for oral administration contains the following inactive ingredients: Anhydrous Lactose, Sodium Lauryl Sulfate, Microcrystalline Cellulose (101), Colloidal Silicon Dioxide, Sodium Starch Glycolate (Type A), Magnesium Stearate, HPMC 2910/ Hypromellose, Macrogol/ PEG (MW 400), Macrogol/ PEG (MW 8000), Titanium Dioxide. Also, the tablet contains Polyvinyl Alcohol Part Hydrolyzed (used for 0.25, 0.5, 2, 3, 4 mg tablets), Macrogol/ PEG (MW 3350) (used for 0.25, 0.5, 2, 3, 4 mg tablets), Talc (used for 0.25, 0.5, 2, 3, 4 mg tablets), D&amp;C Yellow #10 Aluminium Lake (used for 0.25, 4 mg tablets), FD&amp;C Yellow #6/ Sunset Yellow FCF Aluminium Lake (used for 0.25, 2, 4 mg tablets), Iron Oxide Red (used for 0.5 mg tablets), Lactose Monohydrate, Triacetin &amp; Stearic Acid (used for 1 mg tablets), FD&amp;C Red #40/Allura Red AC Aluminum Lake (used for 2 mg tablets) ,Iron Oxide Yellow (used for 3 mg tablets) and FD&amp;C Blue #1/ Brilliant Blue FCF Aluminium Lake (used for 4 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-977-05</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (43598-977-05)  / 50 g in 1 TUBE</PackageDescription>
    <NDC11Code>43598-0977-05</NDC11Code>
    <ProductNDC>43598-977</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium Topical Gel, 1%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200914</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210986</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210131</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) . this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57297-977-05</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (57297-977-05)  / 50 kg in 1 BAG</PackageDescription>
    <NDC11Code>57297-0977-05</NDC11Code>
    <ProductNDC>57297-977</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20191205</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>LUPIN LIMITED</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-01-18</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>05-DEC-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>57691-977-50</NDCCode>
    <PackageDescription>50 mL in 1 TUBE (57691-977-50) </PackageDescription>
    <NDC11Code>57691-0977-50</NDC11Code>
    <ProductNDC>57691-977</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vitamin C Glow-protect Spf 30</ProprietaryName>
    <NonProprietaryName>Octisalate, Avobenzone, Octinoxate, And Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20201031</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Buth-Na-Bodhaige, Inc.,</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>.02; .075; .05; .05</StrengthNumber>
    <StrengthUnit>g/mL; g/mL; g/mL; g/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70954-005-50</NDCCode>
    <PackageDescription>100 BLISTER PACK in 1 CARTON (70954-005-50)  / 1 TABLET in 1 BLISTER PACK (70954-005-40) </PackageDescription>
    <NDC11Code>70954-0005-50</NDC11Code>
    <ProductNDC>70954-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209823</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
    <Description>Each scored oxybutynin chloride tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is C22H31NO3HCl. The structural formula appears below. Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride Tablets, USP also contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose. Oxybutynin chloride tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-019-50</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (70954-019-50) </PackageDescription>
    <NDC11Code>70954-0019-50</NDC11Code>
    <ProductNDC>70954-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210971</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prazosin Hydrochloride Capsules, USP is 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 this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Molecular formula C19H21N5O4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Yellow No. 10 and FD&amp;C Green No. 3; the 2 mg empty gelatin capsules contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1 and FD&amp;C Red No. 40; and the 5 mg empty gelatin capsules contain FD&amp;C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-052-10</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (70954-052-10) </PackageDescription>
    <NDC11Code>70954-0052-10</NDC11Code>
    <ProductNDC>70954-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217881</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Non suppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Serum sickness. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Iritis and iridocyclitis. Chorioretinitis. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of Hydrocortisone, USP. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. FDA approved dissolution test and specifications differs from the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-158-50</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-158-50)  / 1 TABLET in 1 BLISTER PACK (70954-158-40) </PackageDescription>
    <NDC11Code>70954-0158-50</NDC11Code>
    <ProductNDC>70954-158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
    <NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213730</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.</IndicationAndUsage>
    <Description>Chemically, clorazepate dipotassium is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows. The compound occurs as a fine, white or light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Each Clorazepate Dipotassium Tablet, USP 3.75 mg contains clorazepate equivalent to 2.9 mg. Each Clorazepate Dipotassium Tablet, USP 7.5 mg contains clorazepate equivalent to 5.8 mg. Each Clorazepate Dipotassium Tablet, USP 15 mg contains clorazepate equivalent to 11.6 mg. Inactive ingredients for Clorazepate Dipotassium Tablets, USP: Colloidal Silicon Dioxide, FD&amp;C Blue No.2 Aluminum Lake (3.75 mg), FD&amp;C Yellow No.6 Aluminum Lake (7.5 mg), Magnesium Oxide, Potassium Chloride, Potassium Carbonate, Microcrystalline Cellulose, Croscarmellose Sodium and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-159-50</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-159-50)  / 1 TABLET in 1 BLISTER PACK (70954-159-40) </PackageDescription>
    <NDC11Code>70954-0159-50</NDC11Code>
    <ProductNDC>70954-159</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clorazepate Dipotassium</ProprietaryName>
    <NonProprietaryName>Clorazepate Dipotassium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220616</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213730</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>CLORAZEPATE DIPOTASSIUM</SubstanceName>
    <StrengthNumber>3.75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250615</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal.</IndicationAndUsage>
    <Description>Chemically, clorazepate dipotassium is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-1, 4 Benzodiazepine-3-carboxylic acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows. The compound occurs as a fine, white or light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline. Each Clorazepate Dipotassium Tablet, USP 3.75 mg contains clorazepate equivalent to 2.9 mg. Each Clorazepate Dipotassium Tablet, USP 7.5 mg contains clorazepate equivalent to 5.8 mg. Each Clorazepate Dipotassium Tablet, USP 15 mg contains clorazepate equivalent to 11.6 mg. Inactive ingredients for Clorazepate Dipotassium Tablets, USP: Colloidal Silicon Dioxide, FD&amp;C Blue No.2 Aluminum Lake (3.75 mg), FD&amp;C Yellow No.6 Aluminum Lake (7.5 mg), Magnesium Oxide, Potassium Chloride, Potassium Carbonate, Microcrystalline Cellulose, Croscarmellose Sodium and Magnesium Stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-316-10</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (70954-316-10) </PackageDescription>
    <NDC11Code>70954-0316-10</NDC11Code>
    <ProductNDC>70954-316</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210420</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215043</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine for oral suspension is indicated in adults for the treatment of: : 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy., 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias)., 6 reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
    <Description>The active ingredient in famotidine for oral suspension USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio] propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each 5 mL of Famotidine for Oral Suspension USP, when prepared as directed contains 40 mg of famotidine and the following inactive ingredients: citric acid anhydrous, microcrystalline cellulose, carboxymethylcellulose sodium, sucrose, xanthan gum, banana and cherry flavor. Added as preservatives are methylparaben sodium, propylparaben sodium and sodium benzoate. Famotidine is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and glacial acetic acid; slightly soluble in methanol; very slightly soluble in water; and practically insoluble in chloroform, ether and ethyl acetate.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-518-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (70954-518-10)  &gt; 50 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>70954-0518-10</NDC11Code>
    <ProductNDC>70954-518</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216250</ApplicationNumber>
    <LabelerName>Novitium Pharma LLC</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-03-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine hydrochloride is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride Topical Solution, USP contains a local anesthetic agent and is administered topically. See INDICATIONS for specific uses. Each mL contains. Lidocaine Hydrochloride, USP ................................................................................... 40 mg. Methylparaben, Sodium Hydroxide (to adjust pH) in an aqueous solution. NOT FOR INJECTION. Lidocaine is a local anesthetic chemically designated as 2-(diethylamino)-N-(2,6-dimethyl-phenyl)-acetamide. It has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-646-10</NDCCode>
    <PackageDescription>50 g in 1 BOTTLE, PUMP (70954-646-10) </PackageDescription>
    <NDC11Code>70954-0646-10</NDC11Code>
    <ProductNDC>70954-646</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>GEL, METERED</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241023</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217882</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.75</StrengthNumber>
    <StrengthUnit>mg/1.25g</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241023</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol gel0.06% is an estrogen indicated for: : 1 Treatment of moderate to severe vasomotor symptoms due to menopause (1.1).</IndicationAndUsage>
    <Description>Estradiol gel contains 0.06 percent estradiol in an absorptive hydroalcoholic gel base for topical application. It is a clear, colorless hydroalcoholic gel. One pump depression of estradiol geldelivers 1.25 g of gel containing 0.75 mg estradiol. Estradiol is a white crystalline powder, chemically described as estra-1,3,5(10)-triene-3,17β-diol. It has an empirical formula of C18H24O2 and molecular weight of 272.39. The structural formula is. The active component of the gel is estradiol. The remaining components of the gel (purified water, alcohol (46%), triethanolamine and carbomer 974P) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-975-50</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70954-975-50) </PackageDescription>
    <NDC11Code>70954-0975-50</NDC11Code>
    <ProductNDC>70954-975</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213676</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>24; 26</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:       : 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-976-50</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (70954-976-50) </PackageDescription>
    <NDC11Code>70954-0976-50</NDC11Code>
    <ProductNDC>70954-976</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sacubitril And Valsartan</ProprietaryName>
    <NonProprietaryName>Sacubitril And Valsartan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213676</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SACUBITRIL; VALSARTAN</SubstanceName>
    <StrengthNumber>49; 51</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Neprilysin Inhibitor [EPC], Neprilysin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sacubitril and valsartan tablets are a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:       : 1 to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (1.1), 2 for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablets reduce NT-proBNP and are expected to improve cardiovascular outcomes. (1.2).</IndicationAndUsage>
    <Description>Sacubitril and valsartan tablets are a combination of a neprilysin inhibitor and an angiotensin II receptor blocker. Sacubitril and valsartan tablets contain a complex comprised of anionic forms of sacubitril and valsartan, and sodium cations in the molar ratio of 1:1:3, respectively. Following oral administration, the complex dissociates into sacubitril (which is further metabolized to LBQ657) and valsartan. The complex is chemically described as Tri sodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3’-methyl-2’-(pentanoyl{2”-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate]. Its molecular formula is C48H55N6O8●3Na. Its molecular mass is 912.95 and its schematic structural formula is. Sacubitril and valsartan tablets are available as film-coated tablets for oral administration, containing 24 mg of sacubitril and 26 mg of valsartan; 49 mg of sacubitril and 51 mg of valsartan; and 97 mg of sacubitril and 103 mg of valsartan. The tablet inactive ingredients are crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. The film-coat inactive ingredients are hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. The film-coat for the 24 mg of sacubitril and 26 mg of valsartan tablet and the 97 mg of sacubitril and 103 mg of valsartan tablet also contains iron oxide black. The film-coat for the 49 mg of sacubitril and 51 mg of valsartan tablet contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-977-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (55700-977-90) </PackageDescription>
    <NDC11Code>55700-0977-90</NDC11Code>
    <ProductNDC>55700-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220712</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202825</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220712</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
    <Description>Sertraline hydrochloride tablets, USP contain sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate anhydrous, D &amp; C Yellow #10 aluminum lake (in 25 mg tablet), FD &amp; C Blue #1 aluminum lake (in 25 mg tablet), FD &amp; C Blue # 2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, iron oxide yellow (in 100 mg tablet), and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-977-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-977-30)</PackageDescription>
    <NDC11Code>60760-0977-30</NDC11Code>
    <ProductNDC>60760-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130808</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090617</ApplicationNumber>
    <LabelerName>St Marys Medical Park Pharmacy</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60760-977-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-977-90) </PackageDescription>
    <NDC11Code>60760-0977-90</NDC11Code>
    <ProductNDC>60760-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130808</StartMarketingDate>
    <EndMarketingDate>20180430</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090617</ApplicationNumber>
    <LabelerName>St Marys Medical Park Pharmacy</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20130808</StartMarketingDatePackage>
    <EndMarketingDatePackage>20180430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>82804-977-00</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (82804-977-00) </PackageDescription>
    <NDC11Code>82804-0977-00</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-977-11</NDCCode>
    <PackageDescription>1000 TABLET, COATED in 1 BOTTLE (82804-977-11) </PackageDescription>
    <NDC11Code>82804-0977-11</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-977-30</NDCCode>
    <PackageDescription>30 TABLET, COATED in 1 BOTTLE (82804-977-30) </PackageDescription>
    <NDC11Code>82804-0977-30</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-977-55</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (82804-977-55) </PackageDescription>
    <NDC11Code>82804-0977-55</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-977-60</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (82804-977-60) </PackageDescription>
    <NDC11Code>82804-0977-60</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-977-72</NDCCode>
    <PackageDescription>120 TABLET, COATED in 1 BOTTLE (82804-977-72) </PackageDescription>
    <NDC11Code>82804-0977-72</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-977-90</NDCCode>
    <PackageDescription>90 TABLET, COATED in 1 BOTTLE (82804-977-90) </PackageDescription>
    <NDC11Code>82804-0977-90</NDC11Code>
    <ProductNDC>82804-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Spironolactone</ProprietaryName>
    <NonProprietaryName>Spironolactone</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040750</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SPIRONOLACTONE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Spironolactone is an aldosterone antagonist indicated for: : 1 The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1)., 2 Use as an add-on therapy 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 (1.2)., 3 The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response (1.3)., 4 Treatment of primary hyperaldosteronism for: (1.4)oShort-term preoperative treatmentoLong-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia.</IndicationAndUsage>
    <Description>Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17‑ hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula. Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N &amp; A mint flavor, polyethylene glycol, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-057-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (70954-057-10) </PackageDescription>
    <NDC11Code>70954-0057-10</NDC11Code>
    <ProductNDC>70954-057</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211575</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions:Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first 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 thyroiditisRheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitisCollagen Diseases During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis.Dermatologic Diseases Pemphigus, Bullous dermatitis herpetiformis, severe erythema multiforme (stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.Respiratory Diseases Symptomatic sarcoidosis, loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis.Hematologic Disorders Idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia.Neoplastic Diseases For palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood.Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosusGastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritisNervous System Acute exacerbations of multiple sclerosisMiscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone Tablets, USP are available for oral administration containing 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg of prednisone, USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate and sodium starch glycolate. Prednisone Tablets, USP contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione, 17,21-dihydroxy-. The structural formula is represented below. Molecular Formula: C21H26O5. Molecular Weight: 358.44. Prednisone is a white or almost white crystalline powder. It is slightly soluble in acetone, ethanol, ethylacetate and methanol. Meets USP Dissolution Test 2.</Description>
  </NDC>
</NDCList>