RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>60219-2132-3</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (60219-2132-3) </PackageDescription>
    <NDC11Code>60219-2132-03</NDC11Code>
    <ProductNDC>60219-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216599</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment. Doxycycline hyclate tablets are indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
    <Description>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION. Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets, USP, for oral administration. The chemical designation for doxycycline hyclate, USP is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The molecular formula for doxycycline hyclate, USP is [C22H21N2O8HCl]2C2H6OH2O and the molecular weight is 1025.87 g/mol. The structural formula of doxycycline hyclate, USP is. Doxycycline hyclate, USP is a yellow color crystalline powder. It is soluble in water and in solutions of alkali hydroxides and carbonates; slightly soluble in alcohol; practically insoluble in chloroform and in ether. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each film-coated tablet contains 115.41 mg doxycycline hyclate, USP equivalent to 100 mg doxycycline, USP. Inactive ingredients for the tablet formulation are: croscarmellose sodium; FD&amp;C blue #2, iron oxide yellow; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyvinyl alcohol-part. hydrolyzed; sodium lauryl sulfate; talc and titanium dioxide. Meet USP Dissolution Test 5.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2132-1</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (60219-2132-1) </PackageDescription>
    <NDC11Code>60219-2132-01</NDC11Code>
    <ProductNDC>60219-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216599</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment. Doxycycline hyclate tablets are indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
    <Description>To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION. Doxycycline is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate tablets, USP, for oral administration. The chemical designation for doxycycline hyclate, USP is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The molecular formula for doxycycline hyclate, USP is [C22H21N2O8HCl]2C2H6OH2O and the molecular weight is 1025.87 g/mol. The structural formula of doxycycline hyclate, USP is. Doxycycline hyclate, USP is a yellow color crystalline powder. It is soluble in water and in solutions of alkali hydroxides and carbonates; slightly soluble in alcohol; practically insoluble in chloroform and in ether. Doxycycline has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each film-coated tablet contains 115.41 mg doxycycline hyclate, USP equivalent to 100 mg doxycycline, USP. Inactive ingredients for the tablet formulation are: croscarmellose sodium; FD&amp;C blue #2, iron oxide yellow; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyvinyl alcohol-part. hydrolyzed; sodium lauryl sulfate; talc and titanium dioxide. Meet USP Dissolution Test 5.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-2132-3</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2132-3)</PackageDescription>
    <NDC11Code>36987-2132-03</NDC11Code>
    <ProductNDC>36987-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trichophyton Mentagrophytes</ProprietaryName>
    <NonProprietaryName>Trichophyton Mentagrophytes</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>TRICHOPHYTON MENTAGROPHYTES</SubstanceName>
    <StrengthNumber>.05</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-2132-3</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-2132-3) </PackageDescription>
    <NDC11Code>37662-2132-03</NDC11Code>
    <ProductNDC>37662-2132</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zincum Bromatum</ProprietaryName>
    <NonProprietaryName>Zincum Bromatum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221219</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>ZINC BROMIDE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>53002-2132-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (53002-2132-3) </PackageDescription>
    <NDC11Code>53002-2132-03</NDC11Code>
    <ProductNDC>53002-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131127</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202180</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Trazodone hydrochloride tablets, USP are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) (   1).</IndicationAndUsage>
    <Description>Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22ClN 5O · HCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, sodium lauryl sulfate, and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>55154-2132-5</NDCCode>
    <PackageDescription>5 POUCH in 1 BAG (55154-2132-5)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>55154-2132-05</NDC11Code>
    <ProductNDC>55154-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20230116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077839</ApplicationNumber>
    <LabelerName>Cardinal Health 107, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
    <Description>Albuterol sulfate inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula:. Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C 13H 21NO 3) 2  H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Sulfate Inhalation Solution 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Sulfate Inhalation Solution 0.083% contains no sulfiting agents or preservatives. Albuterol sulfate inhalation solution is a clear, colorless to light yellow solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>70518-2132-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2132-3) </PackageDescription>
    <NDC11Code>70518-2132-03</NDC11Code>
    <ProductNDC>70518-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190605</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090083</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</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>2023-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-2132-3</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2132-3) </PackageDescription>
    <NDC11Code>71335-2132-03</NDC11Code>
    <ProductNDC>71335-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nifedipine</ProprietaryName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190312</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210614</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic component, but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion, or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta blockers.</IndicationAndUsage>
    <Description>Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4- (2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets are formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the nifedipine extended-release tablet formulation are lactose monohydrate, microcrystalline cellulose, hypromellose, hydroxyethyl cellulose, ethylcellulose, sodium lauryl sulfate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, talc, polyvinyl alcohol, titanium dioxide(30mg and 60mg), iron oxide yellow, iron oxide red, lecithin (soya) (30 mg and 90 mg), iron oxide black (30 mg and 90 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>72162-2132-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (72162-2132-3) </PackageDescription>
    <NDC11Code>72162-2132-03</NDC11Code>
    <ProductNDC>72162-2132</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020622</StartMarketingDate>
    <EndMarketingDate>20251031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075964</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20020622</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets, USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride, USP is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP, and are white in color. Inactive ingredients in the tablet are pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide, hypromellose and polysorbate 80.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1031-7</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (60219-1031-7)  / 1 KIT in 1 BLISTER PACK (60219-1031-6) </PackageDescription>
    <NDC11Code>60219-1031-07</NDC11Code>
    <ProductNDC>60219-1031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</ProprietaryName>
    <NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207514</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
    <Description>Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. .</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1100-3</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (60219-1100-3) </PackageDescription>
    <NDC11Code>60219-1100-03</NDC11Code>
    <ProductNDC>60219-1100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207289</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
    <Description>Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&amp;C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1145-3</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>60219-1145-03</NDC11Code>
    <ProductNDC>60219-1145</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Darunavir</ProprietaryName>
    <NonProprietaryName>Darunavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212493</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DARUNAVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
    <Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. It has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66 g/mol. Darunavir has the following structural formula. Darunavir is a white to creamish solid. It is freely soluble in ethyl acetate and in dichloromethane; practically insoluble in water. Each darunavir tablet contains 600 mg or 800 mg of darunavir. It also contains the inactive ingredients: colloidal silicon dioxide, crospovidone Type A, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A. The 600 mg tablet film-coating, OPADRY-II Orange, contains FD&amp;C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film-coating, OPADRY-II Brown, contains ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1346-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1346-3) </PackageDescription>
    <NDC11Code>60219-1346-03</NDC11Code>
    <ProductNDC>60219-1346</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209744</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1)., 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)., 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.40. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride. Tadalafil tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg are available for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red (10 mg), iron oxide yellow (5 mg, 10 mg, 20 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1347-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1347-3) </PackageDescription>
    <NDC11Code>60219-1347-03</NDC11Code>
    <ProductNDC>60219-1347</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209744</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1)., 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)., 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.40. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride. Tadalafil tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg are available for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red (10 mg), iron oxide yellow (5 mg, 10 mg, 20 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1348-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1348-3) </PackageDescription>
    <NDC11Code>60219-1348-03</NDC11Code>
    <ProductNDC>60219-1348</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209744</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1)., 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)., 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.40. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride. Tadalafil tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg are available for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red (10 mg), iron oxide yellow (5 mg, 10 mg, 20 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1349-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1349-3) </PackageDescription>
    <NDC11Code>60219-1349-03</NDC11Code>
    <ProductNDC>60219-1349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tadalafil</ProprietaryName>
    <NonProprietaryName>Tadalafil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209744</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TADALAFIL</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1)., 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)., 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
    <Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.40. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride. Tadalafil tablets USP, 2.5 mg, 5 mg, 10 mg and 20 mg are available for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide red (10 mg), iron oxide yellow (5 mg, 10 mg, 20 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1362-3</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60219-1362-3)  / 15 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60219-1362-03</NDC11Code>
    <ProductNDC>60219-1362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loteprednol Etabonate</ProprietaryName>
    <NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250522</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217484</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥ 10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
    <Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white crystalline powder. Loteprednol etabonate is represented by the following structural formula. Molecular formula: C24H31ClO7                                Molecular weight: 466.95 g/mol. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate, 5 mg (0.5%). INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 3.5 to 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride, 0.01%.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1366-3</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60219-1366-3)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60219-1366-03</NDC11Code>
    <ProductNDC>60219-1366</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loteprednol Etabonate</ProprietaryName>
    <NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20241218</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216345</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241218</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.</IndicationAndUsage>
    <Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a micronized sterile white to off-white crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. Loteprednol etabonate is represented by the following structural formula. Molecular formula: C24H31ClO7. Molecular weight: 466.95 g/mol. Chemical name: Chloromethyl 11β, 17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate, 17-(ethyl carbonate). Each mL of Loteprednol etabonate ophthalmic suspension, 0.2% contains. ACTIVE: Loteprednol etabonate, 2 mg (0.2%). PRESERVATIVE ADDED: Benzalkonium chloride, 0.01%. INACTIVES: Edetate disodium, glycerin, povidone K 90, tyloxapol and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH between 5.3 to 5.6. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1376-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1376-3)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-1376-03</NDC11Code>
    <ProductNDC>60219-1376</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240527</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216343</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution, 0.25% and 0.5% is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.5 g/mol. Timolol maleate, USP is a white or almost white crystalline powder which is soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform and practically insoluble in ether. Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths: 0.25% and 0.5%. Timolol maleate gel forming solution has a pH between 6.5 to 7.5 and an osmolality between 260 mOsmol/kg to 310 mOsmol/kg. Active:. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Preservative. Benzododecinium bromide, 0.12 mg (0.012%). Inactives. Xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and water for injection. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1377-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1377-3)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-1377-03</NDC11Code>
    <ProductNDC>60219-1377</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240527</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216343</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution, 0.25% and 0.5% is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.5 g/mol. Timolol maleate, USP is a white or almost white crystalline powder which is soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform and practically insoluble in ether. Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths: 0.25% and 0.5%. Timolol maleate gel forming solution has a pH between 6.5 to 7.5 and an osmolality between 260 mOsmol/kg to 310 mOsmol/kg. Active:. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Preservative. Benzododecinium bromide, 0.12 mg (0.012%). Inactives. Xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and water for injection. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1414-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1414-3) </PackageDescription>
    <NDC11Code>60219-1414-03</NDC11Code>
    <ProductNDC>60219-1414</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eltrombopag Olamine</ProprietaryName>
    <NonProprietaryName>Eltrombopag</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212884</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: : 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3) .</IndicationAndUsage>
    <Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4  2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating: D&amp;C red no. 27 (25 mg tablet), D&amp;C yellow no. 10 (25 mg tablet), FD&amp;C blue no. 1 (25 mg and 50 mg tablet), FD&amp;C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1415-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1415-3) </PackageDescription>
    <NDC11Code>60219-1415-03</NDC11Code>
    <ProductNDC>60219-1415</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eltrombopag Olamine</ProprietaryName>
    <NonProprietaryName>Eltrombopag</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212884</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: : 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3) .</IndicationAndUsage>
    <Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4  2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating: D&amp;C red no. 27 (25 mg tablet), D&amp;C yellow no. 10 (25 mg tablet), FD&amp;C blue no. 1 (25 mg and 50 mg tablet), FD&amp;C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1416-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60219-1416-3) </PackageDescription>
    <NDC11Code>60219-1416-03</NDC11Code>
    <ProductNDC>60219-1416</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eltrombopag Olamine</ProprietaryName>
    <NonProprietaryName>Eltrombopag</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212884</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: : 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3) .</IndicationAndUsage>
    <Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4  2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating: D&amp;C red no. 27 (25 mg tablet), D&amp;C yellow no. 10 (25 mg tablet), FD&amp;C blue no. 1 (25 mg and 50 mg tablet), FD&amp;C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1417-3</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60219-1417-3) </PackageDescription>
    <NDC11Code>60219-1417-03</NDC11Code>
    <ProductNDC>60219-1417</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Eltrombopag Olamine</ProprietaryName>
    <NonProprietaryName>Eltrombopag</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212884</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Eltrombopag is a thrombopoietin receptor agonist indicated: : 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1) , 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) , 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3) .</IndicationAndUsage>
    <Description>Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid-2-aminoethanol (1:2). It has the molecular formula C25H22N4O4  2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.48 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is a brown to red color solid, and is slightly soluble in methanol and practically insoluble in cyclohexane. Each eltrombopag tablet contains eltrombopag olamine in the amount of 15.95 mg, 31.90 mg, 63.80 mg or 95.70 mg equivalent to 12.5 mg, 25 mg, 50 mg or 75 mg of eltrombopag free acid respectively. The inactive ingredients of eltrombopag tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone and sodium starch glycolate. Coating: D&amp;C red no. 27 (25 mg tablet), D&amp;C yellow no. 10 (25 mg tablet), FD&amp;C blue no. 1 (25 mg and 50 mg tablet), FD&amp;C blue no. 2 (50 mg tablet), ferrosoferric oxide (75 mg tablet), hypromellose, iron oxide red (75 mg tablet), iron oxide yellow (75 mg tablet), polyethylene glycol, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1420-3</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (60219-1420-3) </PackageDescription>
    <NDC11Code>60219-1420-03</NDC11Code>
    <ProductNDC>60219-1420</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209745</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2­- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53.  The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD &amp; C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1421-3</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (60219-1421-3) </PackageDescription>
    <NDC11Code>60219-1421-03</NDC11Code>
    <ProductNDC>60219-1421</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Silodosin</ProprietaryName>
    <NonProprietaryName>Silodosin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209745</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>SILODOSIN</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Silodosin, a selective alpha-1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Silodosin capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
    <Description>Silodosin is a selective antagonist of alpha-1 adrenoreceptors. The chemical name of silodosin is 1-(3-Hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2­- trifluoroethoxy)phenoxy]ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide and the molecular formula is C25H32F3N3O4 with a molecular weight of 495.53.  The structural formula of silodosin is. Silodosin is a white to pale yellowish white powder that melts at approximately 105° to 109°C. It is very soluble in acetic acid, freely soluble in alcohol, and very slightly soluble in water. Each silodosin capsules, 4 mg and 8 mg for oral administration contains 4 mg or 8 mg silodosin respectively and inactive ingredients: gelatin, mannitol, pregelatinized starch [Botanical source: corn (maize)], sodium lauryl sulphate, sodium stearyl fumarate and titanium dioxide. Each capsule of 4 mg and 8 mg are imprinted with gold pharmaceutical ink or green pharmaceutical ink respectively and contains: FD &amp; C blue #2 aluminum lake (green pharmaceutical ink), butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution, titanium dioxide (green pharmaceutical ink), and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1526-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1526-3)  / 3 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-1526-03</NDC11Code>
    <ProductNDC>60219-1526</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bromfenac</ProprietaryName>
    <NonProprietaryName>Bromfenac</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210962</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>BROMFENAC SODIUM</SubstanceName>
    <StrengthNumber>.7</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.</IndicationAndUsage>
    <Description>Bromfenac ophthalmic solution, 0.07% is a sterile, nonsteroidal anti-inflammatory drug (NSAID) for topical ophthalmic use. Each mL of bromfenac ophthalmic solution contains 0.805 mg bromfenac sodium sesquihydrate (equivalent to 0.7 mg bromfenac free acid). The USAN name for bromfenac sodium sesquihydrate is bromfenac sodium. Bromfenac sodium is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenylacetate sesquihydrate, with a molecular formula of C15H11BrNNaO31.5 H2O. The chemical structure for bromfenac sodium sesquihydrate is. Bromfenac sodium is a bright orange to yellow powder. It is freely soluble in water, soluble in methanol and very slightly soluble in chloroform, dilute acid and diluted base. The molecular weight of bromfenac sodium is 383.17 g/mol. Bromfenac ophthalmic solution is a clear, yellow solution and supplied as a sterile aqueous 0.07% solution, with a pH of 7.8. The osmolality of bromfenac ophthalmic solution is approximately 300 mOsmol/kg. Each mL of bromfenac ophthalmic solution contains. Active: Each mL contains bromfenac sodium sesquihydrate 0.0805%, which is equivalent to bromfenac free acid 0.07%. Inactives: boric acid, edetate disodium, povidone, sodium borate, sodium sulfite, tyloxapol, sodium hydroxide to adjust pH, and water for injection, USP. Preservative: benzalkonium chloride 0.005%.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1585-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3)  / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-1585-03</NDC11Code>
    <ProductNDC>60219-1585</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluorometholone Ophthalmic Suspension</ProprietaryName>
    <NonProprietaryName>Fluorometholone</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20230109</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216348</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>FLUOROMETHOLONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.</IndicationAndUsage>
    <Description>Fluorometholone Ophthalmic Suspension USP, 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Fluorometholone, USP is practically white crystalline powder. It is practically insoluble in water, slightly soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether. Chemical name: 9-Fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Structural formula. Molecular weight: 376.5 g/mol. Molecular formula: C22H29FO4. Each mL of fluorometholone ophthalmic suspension USP, 0.1% contains. Active: Fluorometholone USP, 0.1% (1 mg). Preservative: Benzalkonium chloride, 0.004% (0.04 mg). Inactives: Edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; water for injection; sodium chloride; sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate; and sodium hydroxide to adjust pH. Fluoromethonolone ophthamic suspension, USP is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290 mOsm/kg to 350 mOsm/kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1617-3</NDCCode>
    <PackageDescription>30 POUCH in 1 CARTON (60219-1617-3)  / 1.58 g in 1 POUCH (60219-1617-1) </PackageDescription>
    <NDC11Code>60219-1617-03</NDC11Code>
    <ProductNDC>60219-1617</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride</ProprietaryName>
    <NonProprietaryName>Potassium Chloride</NonProprietaryName>
    <DosageFormName>FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231125</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210902</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>g/1.58g</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium chloride for oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
    <Description>Potassium chloride, USP is a white granular powder. It is freely soluble in water and insoluble in alcohol. Chemically, potassium chloride is K-Cl with a molecular mass of 74.55 g/mol. Each pouch of light pink to orange powder with an orange odor contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&amp;C Yellow #6, natural and artificial orange flavor (acacia, alpha-tocopherol), and sucralose.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1637-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (60219-1637-3) </PackageDescription>
    <NDC11Code>60219-1637-03</NDC11Code>
    <ProductNDC>60219-1637</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aminocaproic Acid</ProprietaryName>
    <NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20191130</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212492</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>AMINOCAPROIC ACID</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (see WARNINGS).</IndicationAndUsage>
    <Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is a fine, white to almost white, crystalline powder. It is freely soluble in water, in acids, and in alkaline solutions; it is slightly soluble in methanol and practically insoluble in chloroform and in ether. Each aminocaproic acid tablet, USP for oral administration contains 500 mg of aminocaproic acid, USP and the following inactive ingredients: crospovidone type B, magnesium stearate, povidone and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
</NDCList>