RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>45861-082-06</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (45861-082-06)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>45861-0082-06</NDC11Code>
    <ProductNDC>45861-082</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zinc Oxide 20%</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250201</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Pharmaceutica North America, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20250201</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>45861-009-06</NDCCode>
    <PackageDescription>10 g in 1 PACKET (45861-009-06)</PackageDescription>
    <NDC11Code>45861-0009-06</NDC11Code>
    <ProductNDC>45861-009</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Medrox</ProprietaryName>
    <NonProprietaryName>Menthol, Capsaicin, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111027</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Pharmaceutica North America, Inc.</LabelerName>
    <SubstanceName>MENTHOL; CAPSAICIN; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>5; .0375; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>45861-083-06</NDCCode>
    <PackageDescription>2 BOTTLE in 1 BOX (45861-083-06)  / 476 d in 1 BOTTLE</PackageDescription>
    <NDC11Code>45861-0083-06</NDC11Code>
    <ProductNDC>45861-083</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</ProprietaryName>
    <NonProprietaryName>Polyethylene Glycol 3350, Nf Powder For Solution, Laxative</NonProprietaryName>
    <DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090812</ApplicationNumber>
    <LabelerName>Pharmaceutica North America, Inc.</LabelerName>
    <SubstanceName>POLYETHYLENE GLYCOL 3350</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/d</StrengthUnit>
    <Pharm_Classes>Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 1 to 3 days.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16714-082-06</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (16714-082-06)</PackageDescription>
    <NDC11Code>16714-0082-06</NDC11Code>
    <ProductNDC>16714-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040842</ApplicationNumber>
    <LabelerName>Northstar RxLLC</LabelerName>
    <SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-07-17</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>42291-082-06</NDCCode>
    <PackageDescription>6 TABLET, FILM COATED in 1 BOTTLE (42291-082-06) </PackageDescription>
    <NDC11Code>42291-0082-06</NDC11Code>
    <ProductNDC>42291-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azithromycin</ProprietaryName>
    <NonProprietaryName>Azithromycin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220411</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210000</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220411</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azithromycin tablets are macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration ( 2)].</IndicationAndUsage>
    <Description>Azithromycin tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)­13-[(2,6-dideoxy-3-C-methyl-3-O-methyl- α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- β-D-xylo-hexopyranosyl]oxy]-1­ oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38H 72N 2O 12, and its molecular weight is 749.00. Azithromycin has the following structural formula:. Azithromycin, as the dihydrate, is a white or almost white powder with a molecular formula of C 38H 72N 2O 122H 2O and a molecular weight of 785.02. Azithromycin is supplied as tablets containing azithromycin dihydrate, USP equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-082-06</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE (63187-082-06) </PackageDescription>
    <NDC11Code>63187-0082-06</NDC11Code>
    <ProductNDC>63187-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meloxicam</ProprietaryName>
    <NonProprietaryName>Meloxicam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070307</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077927</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>MELOXICAM</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: : 1 Osteoarthritis (OA) (1.1) , 2 Rheumatoid Arthritis (RA) (1.2).</IndicationAndUsage>
    <Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>64330-082-06</NDCCode>
    <PackageDescription>4 kg in 1 DRUM (64330-082-06) </PackageDescription>
    <NDC11Code>64330-0082-06</NDC11Code>
    <ProductNDC>64330-082</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Chlordiazepoxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20151001</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>CHLORDIAZEPOXIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2024-07-23</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-OCT-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-082-06</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (68382-082-06) </PackageDescription>
    <NDC11Code>68382-0082-06</NDC11Code>
    <ProductNDC>68382-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aripiprazole</ProprietaryName>
    <NonProprietaryName>Aripiprazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190604</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090472</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>ARIPIPRAZOLE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190604</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: 1 Schizophrenia (14.1), 2 Irritability Associated with Autistic Disorder (14.4), 3 Treatment of Tourette's disorder (14.5).</IndicationAndUsage>
    <Description>Aripiprazole is an atypical antipsychotic drug that is available as tablets. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1- piperazinyl]butoxy]-3,4-dihydrocarbostyril. The molecular formula is C23H27Cl2N3O2 and its molecular weight is 448.39. The chemical structure is. Each aripiprazole tablet intended for oral administration contains 2 mg or 5 mg or 10 mg or 15 mg or 20 mg or 30 mg of aripiprazole, USP. In addition, each tablet contains the following inactive ingredients: aspartame, calcium stearate, crospovidone and mannitol. Each tablet except 2 mg strength also contains flavor firmenich powder peppermint. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72578-082-06</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (72578-082-06)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>72578-0082-06</NDC11Code>
    <ProductNDC>72578-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Acyclovir</ProprietaryName>
    <NonProprietaryName>Acyclovir</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200608</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205974</ApplicationNumber>
    <LabelerName>Viona Pharmaceuticals Inc</LabelerName>
    <SubstanceName>ACYCLOVIR</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.</IndicationAndUsage>
    <Description>Acyclovir Ointment USP, 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white to off-white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:.</Description>
  </NDC>
  <NDC>
    <NDCCode>50814-082-00</NDCCode>
    <PackageDescription>.8 g in 1 POUCH (50814-082-00) </PackageDescription>
    <NDC11Code>50814-0082-00</NDC11Code>
    <ProductNDC>50814-082</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Genuine First Aid Alcohol Cleansing Pad</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>CLOTH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230111</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>GFA Production(Xiamen) Co.,Ltd</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-06-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For preparation of the skin before injection.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>57237-082-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (57237-082-01)</PackageDescription>
    <NDC11Code>57237-0082-01</NDC11Code>
    <ProductNDC>57237-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091388</ApplicationNumber>
    <LabelerName>Citron Pharma LLC</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-06</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>57237-082-99</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (57237-082-99)</PackageDescription>
    <NDC11Code>57237-0082-99</NDC11Code>
    <ProductNDC>57237-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Quetiapine Fumarate</ProprietaryName>
    <NonProprietaryName>Quetiapine Fumarate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091388</ApplicationNumber>
    <LabelerName>Citron Pharma LLC</LabelerName>
    <SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-06</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61919-082-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (61919-082-20) </PackageDescription>
    <NDC11Code>61919-0082-20</NDC11Code>
    <ProductNDC>61919-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062676</ApplicationNumber>
    <LabelerName>DIRECT RX</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>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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 is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. 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. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, D&amp;C Red #28, FD&amp;C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&amp;C Yellow #10 aluminum lake, FD&amp;C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-082-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (61919-082-30) </PackageDescription>
    <NDC11Code>61919-0082-30</NDC11Code>
    <ProductNDC>61919-082</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
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    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
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    <LastUpdate>2026-03-06</LastUpdate>
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    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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 is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. 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. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, D&amp;C Red #28, FD&amp;C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&amp;C Yellow #10 aluminum lake, FD&amp;C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
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    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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 is an antibacterial drug synthetically derived from oxytetracycline, and is available as doxycycline hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) capsules and tablets for oral administration. The chemical designation of this light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. 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. Doxycycline hyclate has the following structural formula. Each capsule for oral administration contains doxycycline hyclate equivalent to 50 mg or 100 mg doxycycline (anhydrous). Inactive ingredients for capsules are: anhydrous lactose, croscarmellose sodium, D&amp;C Red #28, FD&amp;C Blue #1, gelatin, magnesium stearate, microcrystalline cellulose, and titanium dioxide. Each tablet for oral administration contains doxycycline hyclate equivalent to 100 mg doxycycline. Inactive ingredients for tablets are: anhydrous lactose, carnauba wax, croscarmellose sodium, D&amp;C Yellow #10 aluminum lake, FD&amp;C Red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.</Description>
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    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tabletsmay be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, red iron oxide, yellow iron oxide, black iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Drug product complies with USP Dissolution Test 2.</Description>
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    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tabletsmay be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, red iron oxide, yellow iron oxide, black iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Drug product complies with USP Dissolution Test 2.</Description>
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    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tabletsmay be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, red iron oxide, yellow iron oxide, black iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Drug product complies with USP Dissolution Test 2.</Description>
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    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201662</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>320; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and hydrochlorothiazide tabletsmay be substituted for the titrated components. Initial Therapy. Valsartan and hydrochlorothiazide tablets may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of valsartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide tablets are combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan, USP is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, red iron oxide, yellow iron oxide, black iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide. Drug product complies with USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-873-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65162-873-06) </PackageDescription>
    <NDC11Code>65162-0873-06</NDC11Code>
    <ProductNDC>65162-873</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bosentan</ProprietaryName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209742</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BOSENTAN ANHYDROUS</SubstanceName>
    <StrengthNumber>62.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-­[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to yellowish powder. It is poorly soluble in water (1 mg/100 mL) and in aqueous solutions at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan tablets are available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contain the following excipients: corn starch, ethyl cellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, pregelatinized starch, povidone, sodium starch glycolate type A, titanium dioxide, triacetin and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-874-06</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65162-874-06) </PackageDescription>
    <NDC11Code>65162-0874-06</NDC11Code>
    <ProductNDC>65162-874</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bosentan</ProprietaryName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190426</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209742</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>BOSENTAN ANHYDROUS</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190426</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-­[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-[2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white to yellowish powder. It is poorly soluble in water (1 mg/100 mL) and in aqueous solutions at low pH (0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility increases at higher pH values (43 mg/100 mL at pH 7.5). In the solid state, bosentan is very stable, is not hygroscopic and is not light sensitive. Bosentan tablets are available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contain the following excipients: corn starch, ethyl cellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, pregelatinized starch, povidone, sodium starch glycolate type A, titanium dioxide, triacetin and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of anhydrous bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of anhydrous bosentan.</Description>
  </NDC>
  <NDC>
    <NDCCode>68196-082-09</NDCCode>
    <PackageDescription>27 LOZENGE in 1 CONTAINER (68196-082-09) </PackageDescription>
    <NDC11Code>68196-0082-09</NDC11Code>
    <ProductNDC>68196-082</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Members Mark Nicotine</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077007</ApplicationNumber>
    <LabelerName>Sam's West Inc</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68196-082-13</NDCCode>
    <PackageDescription>7 CONTAINER in 1 PACKAGE (68196-082-13)  &gt; 27 LOZENGE in 1 CONTAINER</PackageDescription>
    <NDC11Code>68196-0082-13</NDC11Code>
    <ProductNDC>68196-082</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Members Mark Nicotine</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077007</ApplicationNumber>
    <LabelerName>Sam's West Inc</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150729</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68196-082-14</NDCCode>
    <PackageDescription>8 CONTAINER in 1 PACKAGE (68196-082-14)  / 27 LOZENGE in 1 CONTAINER (68196-082-09) </PackageDescription>
    <NDC11Code>68196-0082-14</NDC11Code>
    <ProductNDC>68196-082</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Members Mark Nicotine</ProprietaryName>
    <NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150729</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077007</ApplicationNumber>
    <LabelerName>Sam's West Inc</LabelerName>
    <SubstanceName>NICOTINE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68382-446-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (68382-446-01) </PackageDescription>
    <NDC11Code>68382-0446-01</NDC11Code>
    <ProductNDC>68382-446</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bosentan</ProprietaryName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207760</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>BOSENTAN</SubstanceName>
    <StrengthNumber>62.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-446-05</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (68382-446-05) </PackageDescription>
    <NDC11Code>68382-0446-05</NDC11Code>
    <ProductNDC>68382-446</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bosentan</ProprietaryName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207760</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>BOSENTAN</SubstanceName>
    <StrengthNumber>62.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
  </NDC>
  <NDC>
    <NDCCode>68382-446-14</NDCCode>
    <PackageDescription>60 TABLET, COATED in 1 BOTTLE (68382-446-14) </PackageDescription>
    <NDC11Code>68382-0446-14</NDC11Code>
    <ProductNDC>68382-446</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bosentan</ProprietaryName>
    <NonProprietaryName>Bosentan</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207760</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>BOSENTAN</SubstanceName>
    <StrengthNumber>62.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190501</StartMarketingDatePackage>
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    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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    <IndicationAndUsage>Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): 1 in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)]., 2 in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.</IndicationAndUsage>
    <Description>Bosentan is an endothelin receptor antagonist that belongs to a class of highly substituted pyrimidine derivatives, with no chiral centers. It is designated chemically as 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)- [2,2´]-bipyrimidin-4-yl]- benzenesulfonamide monohydrate and has the following structural formula. Bosentan has a molecular weight of 569.64 and a molecular formula of C27H29N5O6SH2O. Bosentan is a white yellowish powder and it is Soluble in acetonitrile, slightly soluble in methanol and practically insoluble in water. Bosentan is available as 62.5 mg and 125 mg film-coated tablets for oral administration, and contains the following excipients: corn starch, ethylcellulose, glyceryl behenate, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, and talc. Each bosentan 62.5 mg tablet contains 64.541 mg of bosentan monohydrate, equivalent to 62.5 mg of bosentan. Each bosentan 125 mg tablet contains 129.082 mg of bosentan monohydrate, equivalent to 125 mg of bosentan.</Description>
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