RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>76282-694-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (76282-694-05) </PackageDescription>
    <NDC11Code>76282-0694-05</NDC11Code>
    <ProductNDC>76282-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207446</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
    <Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-694-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (76282-694-01) </PackageDescription>
    <NDC11Code>76282-0694-01</NDC11Code>
    <ProductNDC>76282-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Celecoxib</ProprietaryName>
    <NonProprietaryName>Celecoxib</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207446</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc</LabelerName>
    <SubstanceName>CELECOXIB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Celecoxib is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) (1.1), 2 Rheumatoid Arthritis (RA) (1.2), 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older (1.3), 4 Ankylosing Spondylitis (AS) (1.4), 5 Acute Pain (AP) (1.5), 6 Primary Dysmenorrhea (PD) (1.6).</IndicationAndUsage>
    <Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
  </NDC>
  <NDC>
    <NDCCode>13517-694-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (13517-694-05) </PackageDescription>
    <NDC11Code>13517-0694-05</NDC11Code>
    <ProductNDC>13517-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221130</StartMarketingDate>
    <EndMarketingDate>20261130</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>e5 Pharma, LLC</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221130</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
    <Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 15 mg, 30 mg, 60 mg, or 100 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-694-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (23155-694-05) </PackageDescription>
    <NDC11Code>23155-0694-05</NDC11Code>
    <ProductNDC>23155-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Allopurinol</ProprietaryName>
    <NonProprietaryName>Allopurinol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200922</StartMarketingDate>
    <EndMarketingDate>20291031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204467</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ALLOPURINOL</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200922</StartMarketingDatePackage>
    <EndMarketingDatePackage>20291031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Allopurinol Tablets are indicated for: : 1 The management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) , 2 The management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels  , 3 The management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxylate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) .</IndicationAndUsage>
    <Description>Allopurinol is a xanthine oxidase inhibitor. It has the following structural formula. Allopurinol tablets are known chemically as 1, 5-dihydro-4H-pyrazolo [3, 4-d]pyrimidin-4-one and it has a molecular weight of 136.11 g/mol. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution. It is a xanthine oxidase inhibitor which is administered orally. Each scored white, flat cylindrical tablet contains 100 mg allopurinol and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone and purified water.  Each scored peach, flat cylindrical tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&amp;C Yellow No. 6 Aluminium Lake, lactose monohydrate, magnesium stearate, povidone and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-694-05</NDCCode>
    <PackageDescription>5 TABLET in 1 BOTTLE (35356-694-05)</PackageDescription>
    <NDC11Code>35356-0694-05</NDC11Code>
    <ProductNDC>35356-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA071404</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-09</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51293-694-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (51293-694-05) </PackageDescription>
    <NDC11Code>51293-0694-05</NDC11Code>
    <ProductNDC>51293-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200301</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>ECI Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-08-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63304-694-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (63304-694-05)</PackageDescription>
    <NDC11Code>63304-0694-05</NDC11Code>
    <ProductNDC>63304-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20001222</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065062</ApplicationNumber>
    <LabelerName>Ranbaxy Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC],Tetracyclines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydia psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Calymmatobacterium granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:. Upper respiratory tract infections caused by Streptococcus pneumoniae. Skin and skin structure infections caused by Staphylococcus aureus. (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:. Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum subspecies pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Anthrax due to Bacillus anthracis. Vincent’s infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis (dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C23H27N3O7HCl M.W. 493.95. Each minocycline hydrochloride capsule, USP for oral administration, contains the equivalent of 50 mg, 75 mg or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: corn starch and magnesium stearate. The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and titanium dioxide. The 75 mg and 100 mg capsule shells also contain black iron oxide. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-694-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (65862-694-05) </PackageDescription>
    <NDC11Code>65862-0694-05</NDC11Code>
    <ProductNDC>65862-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150529</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203974</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole 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.</IndicationAndUsage>
    <Description>Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole USP. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>68428-694-05</NDCCode>
    <PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-694-05) </PackageDescription>
    <NDC11Code>68428-0694-05</NDC11Code>
    <ProductNDC>68428-694</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vanadium Metallicum</ProprietaryName>
    <NonProprietaryName>Vanadium</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>VANADIUM</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-04-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69367-694-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (69367-694-05) </PackageDescription>
    <NDC11Code>69367-0694-05</NDC11Code>
    <ProductNDC>69367-694</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenobarbital</ProprietaryName>
    <NonProprietaryName>Phenobarbital</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230908</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>PHENOBARBITAL</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2023-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>A. Sedative. B. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
    <Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5-phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. Each phenobarbital tablet contains 15 mg, 30 mg, 60 mg, or 100 mg of phenobarbital. In addition each tablet contains: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-115-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05) </PackageDescription>
    <NDC11Code>76282-0115-05</NDC11Code>
    <ProductNDC>76282-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamivudine And Zidovudine</ProprietaryName>
    <NonProprietaryName>Lamivudine And Zidovudine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150429</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203259</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LAMIVUDINE; ZIDOVUDINE</SubstanceName>
    <StrengthNumber>150; 300</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-01-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150429</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lamivudine and Zidovudine Tablet, USP a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.</IndicationAndUsage>
    <Description>Lamivudine and Zidovudine Tablets, USP: Lamivudine and Zidovudine Tablets, USP are combination tablets containing lamivudine and zidovudine. Lamivudine and zidovudine (azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1. Lamivudine and Zidovudine Tablets, USP are for oral administration. Each film-coated tablet contains 150 mg of lamivudine USP, 300 mg of zidovudine USP, and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. Lamivudine:  The chemical name of lamivudine is 2(1H) - Pyrimidinone, 4-amino-1- [2- (hydroxymethyl)-1,3-oxathio-lan-5-yl], (2R-cis)-. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.26. It has the following structural formula:. Lamivudine is white to an off-white solid. Soluble in water. Zidovudine:  The chemical name of zidovudine is Thymidine, 3’-azido-3’-deoxy-. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula:. Zidovudine is a white to yellowish powder. Sparingly soluble in water and soluble in alcohol. This product meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-152-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-152-05) </PackageDescription>
    <NDC11Code>76282-0152-05</NDC11Code>
    <ProductNDC>76282-152</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meloxicam</ProprietaryName>
    <NonProprietaryName>Meloxicam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077927</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</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>2023-02-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150414</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), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
    <Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). 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-3-­carboxamide-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>76282-153-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-153-05) </PackageDescription>
    <NDC11Code>76282-0153-05</NDC11Code>
    <ProductNDC>76282-153</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Meloxicam</ProprietaryName>
    <NonProprietaryName>Meloxicam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150414</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077927</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MELOXICAM</SubstanceName>
    <StrengthNumber>15</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>2023-02-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150414</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), 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg (1.3).</IndicationAndUsage>
    <Description>Meloxicam Tablets USP are a nonsteroidal anti-inflammatory drug (NSAID). 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-3-­carboxamide-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>76282-154-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-154-05) </PackageDescription>
    <NDC11Code>76282-0154-05</NDC11Code>
    <ProductNDC>76282-154</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160830</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040907</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
    <Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&amp;C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-155-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-155-05) </PackageDescription>
    <NDC11Code>76282-0155-05</NDC11Code>
    <ProductNDC>76282-155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160830</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040907</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160830</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.</IndicationAndUsage>
    <Description>Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide USP. In addition, each tablet contains the following inactive ingredients: corn starch, FD&amp;C Yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-206-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-206-05) </PackageDescription>
    <NDC11Code>76282-0206-05</NDC11Code>
    <ProductNDC>76282-206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077534</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76282-207-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-207-05) </PackageDescription>
    <NDC11Code>76282-0207-05</NDC11Code>
    <ProductNDC>76282-207</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077534</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76282-208-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-208-05) </PackageDescription>
    <NDC11Code>76282-0208-05</NDC11Code>
    <ProductNDC>76282-208</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Citalopram Hydrobromide</ProprietaryName>
    <NonProprietaryName>Citalopram</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077534</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Citalopram tablet contains citalopram hydrobromide, an orally administered selective serotonin reuptake inhibitor (SSRI) with a chemical structure unrelated to that of other SSRIs or of tricyclic, tetracyclic, or other available antidepressant agents. Citalopram hydrobromide is a racemic bicyclic phthalane derivative designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3- dihydroisobenzofuran-5-carbonitrile, hydrobromide with the following structural formula. The molecular formula is C20H22BrFN2O and its molecular weight is 405.35. Citalopram hydrobromide occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram is available only in tablet dosage form. Citalopram tablets, USP 10 mg are film-coated, round tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, round, scored tablets containing citalopram hydrobromide in strengths equivalent to 20 mg or 40 mg citalopram base. Their strengths reflect their citalopram base equivalent content. The 10 mg, 20 mg and 40 mg strength tablets contain 12.49 mg, 24.98 mg and 49.96 mg of citalopram hydrobromide, respectively. The tablets also contain the following. Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/ hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coloring agents in the beige (10 mg) and pink (20 mg) and white (40 mg) tablets.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-209-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-209-05) </PackageDescription>
    <NDC11Code>76282-0209-05</NDC11Code>
    <ProductNDC>76282-209</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Terbinafine</ProprietaryName>
    <NonProprietaryName>Terbinafine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120425</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077533</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>TERBINAFINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120425</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Terbinafine tablets, USP are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.</IndicationAndUsage>
    <Description>Terbinafine tablets, USP contain the synthetic allylamine antifungal compound terbinafine hydrochloride. Chemically, terbinafine hydrochloride, USP is (E)-N-(6, 6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.90, and the following structural formula:. Terbinafine hydrochloride, USP is a white to off-white fine crystalline powder. It is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Each tablet contains. Active Ingredients: terbinafine hydrochloride (equivalent to 250 mg base). Inactive Ingredients: colloidal silicon dioxide NF, hypromellose USP, magnesium stearate NF, microcrystalline cellulose NF, and sodium starch glycolate NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-212-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-212-05) </PackageDescription>
    <NDC11Code>76282-0212-05</NDC11Code>
    <ProductNDC>76282-212</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline</ProprietaryName>
    <NonProprietaryName>Sertraline</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077397</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
    <Description>Sertraline contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&amp;C Yellow #10 Aluminum Lake, and FD&amp;C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&amp;C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-213-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-213-05) </PackageDescription>
    <NDC11Code>76282-0213-05</NDC11Code>
    <ProductNDC>76282-213</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline</ProprietaryName>
    <NonProprietaryName>Sertraline</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077397</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
    <Description>Sertraline contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&amp;C Yellow #10 Aluminum Lake, and FD&amp;C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&amp;C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-214-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-214-05) </PackageDescription>
    <NDC11Code>76282-0214-05</NDC11Code>
    <ProductNDC>76282-214</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sertraline</ProprietaryName>
    <NonProprietaryName>Sertraline</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077397</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sertraline tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
    <Description>Sertraline contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&amp;C Yellow #10 Aluminum Lake, and FD&amp;C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&amp;C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-225-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-225-05) </PackageDescription>
    <NDC11Code>76282-0225-05</NDC11Code>
    <ProductNDC>76282-225</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gemfibrozil</ProprietaryName>
    <NonProprietaryName>Gemfibrozil</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061020</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077836</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GEMFIBROZIL</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20061020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
    <Description>Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C15H22O3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-237-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-237-05) </PackageDescription>
    <NDC11Code>76282-0237-05</NDC11Code>
    <ProductNDC>76282-237</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077955</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) Amlodipine besylate tablets, USP 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. , 2  Coronary Artery Disease (1.2)  Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-238-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-238-05) </PackageDescription>
    <NDC11Code>76282-0238-05</NDC11Code>
    <ProductNDC>76282-238</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077955</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) Amlodipine besylate tablets, USP 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. , 2  Coronary Artery Disease (1.2)  Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-239-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (76282-239-05) </PackageDescription>
    <NDC11Code>76282-0239-05</NDC11Code>
    <ProductNDC>76282-239</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amlodipine Besylate</ProprietaryName>
    <NonProprietaryName>Amlodipine Besylate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071102</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077955</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20071102</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: : 1 Hypertension (1.1) Amlodipine besylate tablets, USP 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. , 2  Coronary Artery Disease (1.2)  Chronic Stable AnginaVasospastic Angina (Prinzmetal’s or Variant Angina)Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction &lt; 40%.</IndicationAndUsage>
    <Description>Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S, and its structural formula is:Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate tablets, USP are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-249-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-249-05) </PackageDescription>
    <NDC11Code>76282-0249-05</NDC11Code>
    <ProductNDC>76282-249</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078604</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1), 2 treatment of generalized anxiety disorder (GAD) in adults (1).</IndicationAndUsage>
    <Description>Escitalopram tablets, USP is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg oxalate in strengths equivalent to 5 mg, 10 and 20 mg, respectively, of base. The 10 mg and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, croscarmellose sodium, talc, magnesium stearate, Opadry white (titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol and polysorbate 80).</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-250-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05) </PackageDescription>
    <NDC11Code>76282-0250-05</NDC11Code>
    <ProductNDC>76282-250</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078604</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1), 2 treatment of generalized anxiety disorder (GAD) in adults (1).</IndicationAndUsage>
    <Description>Escitalopram tablets, USP is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg oxalate in strengths equivalent to 5 mg, 10 and 20 mg, respectively, of base. The 10 mg and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, croscarmellose sodium, talc, magnesium stearate, Opadry white (titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol and polysorbate 80).</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-251-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-251-05) </PackageDescription>
    <NDC11Code>76282-0251-05</NDC11Code>
    <ProductNDC>76282-251</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram Oxalate</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078604</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: 1 treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older (1), 2 treatment of generalized anxiety disorder (GAD) in adults (1).</IndicationAndUsage>
    <Description>Escitalopram tablets, USP is a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S- enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. The molecular formula is C20H21FN2O  C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram tablets USP, are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg oxalate in strengths equivalent to 5 mg, 10 and 20 mg, respectively, of base. The 10 mg and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, croscarmellose sodium, talc, magnesium stearate, Opadry white (titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol and polysorbate 80).</Description>
  </NDC>
  <NDC>
    <NDCCode>76282-256-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (76282-256-05) </PackageDescription>
    <NDC11Code>76282-0256-05</NDC11Code>
    <ProductNDC>76282-256</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Raloxifene Hydrochloride</ProprietaryName>
    <NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20141112</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090842</ApplicationNumber>
    <LabelerName>Exelan Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2020-10-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Raloxifene hydrochloride, USP is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is. The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl) ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C28H27NO4SHCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl, USP is an off-white to pale-yellow solid that is very slightly soluble in water. Raloxifene hydrochloride tablets, USP are supplied in a tablet dosage form for oral administration. Each raloxifene hydrochloride tablet contains 60 mg of raloxifene HCl, USP which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include mannitol, crospovidone, hydroxypropyl cellulose, poloxamer 407, magnesium stearate and opadry white (titanium Dioxide, hypromellose 2910 (3cP), hypromellose 2910 (6cP), macrogol/PEG 400 and polysorbate 80).</Description>
  </NDC>
</NDCList>