RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>70954-892-10</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (70954-892-10) </PackageDescription>
    <NDC11Code>70954-0892-10</NDC11Code>
    <ProductNDC>70954-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219918</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Tuberculosis. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. Meningococcal Carriers. Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS.). Rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin 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>Rifampin Capsules, USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: magnesium stearate, docusate sodium, sodium benzoate, pregelatinized starch, talc, microcrystalline cellulose and colloidal silicon dioxide. The hard gelatin capsules contain gelatin, purified water, sodium lauryl sulfate, titanium dioxide, FD&amp;C Red No. 40, D&amp;C Red No. 28 and FD&amp;C Blue No. 1. The imprinting ink contains shellac, black iron oxide, potassium hydroxide and propylene glycol. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-892-20</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-892-20) </PackageDescription>
    <NDC11Code>70954-0892-20</NDC11Code>
    <ProductNDC>70954-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifampin</ProprietaryName>
    <NonProprietaryName>Rifampin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260720</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219918</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIFAMPIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260720</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified. Tuberculosis. Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. Following the initial phase, treatment should be continued with rifampin and isoniazid for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive. Meningococcal Carriers. Rifampin is indicated for the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. Rifampin is not indicated for the treatment of meningococcal infection because of the possibility of the rapid emergence of resistant organisms. (See WARNINGS.). Rifampin should not be used indiscriminately, and, therefore, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed for establishment of the carrier state and the correct treatment. So that the usefulness of rifampin in the treatment of asymptomatic meningococcal carriers is preserved, the drug should be used only when the risk of meningococcal disease is high. To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifampin and other antibacterial drugs, rifampin 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>Rifampin Capsules, USP for oral administration contains 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain, as inactive ingredients: magnesium stearate, docusate sodium, sodium benzoate, pregelatinized starch, talc, microcrystalline cellulose and colloidal silicon dioxide. The hard gelatin capsules contain gelatin, purified water, sodium lauryl sulfate, titanium dioxide, FD&amp;C Red No. 40, D&amp;C Red No. 28 and FD&amp;C Blue No. 1. The imprinting ink contains shellac, black iron oxide, potassium hydroxide and propylene glycol. Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either. 3-[[(4-Methyl-1-piperazinyl)imino]methyl]rifamycin. or. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>10893-892-10</NDCCode>
    <PackageDescription>1 BOTTLE, GLASS in 1 CARTON (10893-892-10)  &gt; 1 LIQUID in 1 BOTTLE, GLASS</PackageDescription>
    <NDC11Code>10893-0892-10</NDC11Code>
    <ProductNDC>10893-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naturasil</ProprietaryName>
    <ProprietaryNameSuffix>Ringworm</ProprietaryNameSuffix>
    <NonProprietaryName>Sulfur</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111001</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Nature's Innovation, Inc.</LabelerName>
    <SubstanceName>SULFUR</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>16714-892-11</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-11)  &gt; 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>16714-0892-11</NDC11Code>
    <ProductNDC>16714-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Daptomycin</ProprietaryName>
    <NonProprietaryName>Daptomycin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208375</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>DAPTOMYCIN</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Lipopeptide Antibacterial [EPC],Lipopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>17478-892-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (17478-892-10)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>17478-0892-10</NDC11Code>
    <ProductNDC>17478-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20080501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077845</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-05-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>31722-892-32</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (31722-892-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-892-31) </PackageDescription>
    <NDC11Code>31722-0892-32</NDC11Code>
    <ProductNDC>31722-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209242</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>20; 5; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
    <Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 1H-Imadazole-5-carboxylic acid, 4-(1-hydroxy-1-methyl-ethyl)- 2-Propyl-1-[[2’-(1H tetrazole-5-yl) [1,1’-biphenyl]-4-yl]methyl-, (5- methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its empirical formula is C 29H 30N 6O 6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 3,5-pyridine  dicarboxylic  acid,  2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl,3-ethyl    5-methyl    ester,     (±)-monobenzene sulfonate. Its empirical formula is C 26H 31CIN 2O 8S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is chemically described as 6-chloro-3, 4-dihydro-2 H-1, 2, 4-benzothiadiazine-7-sulphonamide 1,1- dioxide. Its empirical formula is C 7H 8CIN 3O 4S 2. The structural formula for olmesartan medoxomil is:. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet contains olmesartan medoxomil USP, a white to off-white, crystalline powder, amlodipine besylate USP, a white or almost white powder, and hydrochlorothiazide USP, a white or practically white, practically odourless, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil USP is practically insoluble in water and in heptane, slightly soluble in ethanol (96%), sparingly soluble in methanol. Amlodipine besylate USP is slightly soluble in water, freely soluble in methanol, sparingly soluble in anhydrous ethanol, slightly soluble in 2-propanol. Hydrochlorothiazide USP is very slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethyl formamide, sparingly soluble in methanol, insoluble in ether, in chloroform and in dilute mineral acids. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The color coating contains iron oxide black, iron oxide red, iron oxide yellow, macrogol, polyvinyl alcohol, talc and titanium dioxide. The botanical source for pregelatinized starch is corn starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>37000-892-10</NDCCode>
    <PackageDescription>2 CARTON in 1 CELLO PACK (37000-892-10)  / 1 TUBE in 1 CARTON / 144 g in 1 TUBE</PackageDescription>
    <NDC11Code>37000-0892-10</NDC11Code>
    <ProductNDC>37000-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Crest Pro-health Advanced</ProprietaryName>
    <NonProprietaryName>Stannous Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20161229</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>The Procter &amp; Gamble Manufacturing Company</LabelerName>
    <SubstanceName>STANNOUS FLUORIDE</SubstanceName>
    <StrengthNumber>1.6</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-10-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of cavities. helps prevent gingivitis. helps interfere with the harmful effects of plaque associated with gingivitis. helps control plaque bacteria that contribute to the development of gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49348-892-10</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (49348-892-10)  &gt; 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>49348-0892-10</NDC11Code>
    <ProductNDC>49348-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunmark Pain Relief</ProprietaryName>
    <ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090804</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>McKesson</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>54458-892-10</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (54458-892-10) </PackageDescription>
    <NDC11Code>54458-0892-10</NDC11Code>
    <ProductNDC>54458-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Escitalopram</ProprietaryName>
    <NonProprietaryName>Escitalopram</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130919</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076765</ApplicationNumber>
    <LabelerName>International Laboratories, LLC</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>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130919</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2).</IndicationAndUsage>
    <Description>Escitalopram tablets USP are an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP, is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. C20H21FN2O  C2H2O4  M.W. 414.43. Escitalopram oxalate, USP, 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 escitalopram oxalate, USP, in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55579-892-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (55579-892-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (55579-892-01) </PackageDescription>
    <NDC11Code>55579-0892-10</NDC11Code>
    <ProductNDC>55579-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215260</ApplicationNumber>
    <LabelerName>Solupharm Pharmazeutische Erzeugnisse GmbH</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION ®(sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-Octakis-S-(2-carboxyethyl)- 6 A,6 B,6 C,6 D,6 E,6 F,6 G,6 H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6 A,6 B,6 C,6 D,6 E,6 F,6 G-Heptakis-S-(2- carboxyethyl)-6 A,6 B,6 C,6 D,6 E,6 F,6 G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
  </NDC>
  <NDC>
    <NDCCode>62157-892-01</NDCCode>
    <PackageDescription>10 g in 1 JAR (62157-892-01)</PackageDescription>
    <NDC11Code>62157-0892-01</NDC11Code>
    <ProductNDC>62157-892</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Diethylstilbestrol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20190718</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
    <LabelerName>AX Pharmaceutical Corp</LabelerName>
    <SubstanceName>DIETHYLSTILBESTROL</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>62207-892-51</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (62207-892-51)  / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>62207-0892-51</NDC11Code>
    <ProductNDC>62207-892</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Acetaminophen</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211544</ApplicationNumber>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>650</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-06-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For Arthritis Pain label  temporarily relieves minor aches and pains due to:      minor pain of arthritis      muscular aches      backache      premenstrual and menstrual cramps      the common cold      headache      toothache  temporarily reduces fever. For Muscle Aches &amp; Pain label  temporarily relieves minor aches and pains due to:      muscular aches      backache      minor pain of arthritis      toothache      premenstrual and menstrual cramps      headache      the common cold  temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65862-892-03</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (65862-892-03)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-892-10) </PackageDescription>
    <NDC11Code>65862-0892-03</NDC11Code>
    <ProductNDC>65862-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Voriconazole</ProprietaryName>
    <NonProprietaryName>Voriconazole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206837</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>VORICONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 1 Invasive aspergillosis (1.1) , 2 Candidemia in non-neutropenics and other deep tissue Candida infections (1.2) , 3 Esophageal candidiasis (1.3) , 4 Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy (1.4) .</IndicationAndUsage>
    <Description>Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is. Voriconazole is designated chemically as (2R,3S)-2-(2, 4-difluorophenyl)-3-(5-fluoro-4- pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)-2-butanol with an molecular formula of C16H14F3N5O and a molecular weight of 349.3. Voriconazole USP drug substance is a white to almost white powder. Voriconazole tablets contain 50 mg or 200 mg of voriconazole USP. The inactive ingredients include colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (maize), titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70069-892-10</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70069-892-10)  / 2 mL in 1 VIAL, SINGLE-DOSE (70069-892-01) </PackageDescription>
    <NDC11Code>70069-0892-10</NDC11Code>
    <ProductNDC>70069-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sugammadex</ProprietaryName>
    <NonProprietaryName>Sugammadex</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20260728</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215260</ApplicationNumber>
    <LabelerName>Somerset Therapeutics, LLC</LabelerName>
    <SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp &amp; Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp &amp; Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
    <Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)- 6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2- carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-892-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (76420-892-01)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05)  / 5 mL in 1 VIAL, SINGLE-DOSE *  .9 mL in 1 PACKET (67777-419-02)  *  5 mL in 1 POUCH *  1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01)  / 5 mL in 1 VIAL, MULTI-DOSE *  10 BOTTLE, PLASTIC in 1 BOX (65219-383-05)  / 50 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>76420-0892-01</NDC11Code>
    <ProductNDC>76420-892</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bl-c Kit</ProprietaryName>
    <NonProprietaryName>Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Iodixanol, Povidine Iodine</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVASCULAR; PERINEURAL; TOPICAL</RouteName>
    <StartMarketingDate>20241231</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70954-002-10</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (70954-002-10) </PackageDescription>
    <NDC11Code>70954-0002-10</NDC11Code>
    <ProductNDC>70954-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210681</ApplicationNumber>
    <LabelerName>Novitium Pharma LLC</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-10-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70954-005-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (70954-005-10) </PackageDescription>
    <NDC11Code>70954-0005-10</NDC11Code>
    <ProductNDC>70954-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209823</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Oxybutynin chloride tablets, USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).</IndicationAndUsage>
    <Description>Each scored oxybutynin chloride tablet, USP contains 5 mg of oxybutynin chloride. Chemically, oxybutynin chloride is d, l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The molecular formula of oxybutynin chloride is C22H31NO3HCl. The structural formula appears below. Oxybutynin chloride, USP is a white crystalline solid with a molecular weight of 393.95. It is readily soluble in water and acids, but relatively insoluble in alkalis. Oxybutynin chloride Tablets, USP also contains anhydrous lactose, croscarmellose sodium, magnesium stearate, microcrystalline cellulose. Oxybutynin chloride tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-008-10</NDCCode>
    <PackageDescription>60 CARTON in 1 BOTTLE (70954-008-10)  &gt; 1 CAPSULE in 1 CARTON</PackageDescription>
    <NDC11Code>70954-0008-10</NDC11Code>
    <ProductNDC>70954-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitisinone</ProprietaryName>
    <NonProprietaryName>Nitisinone</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190826</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211041</ApplicationNumber>
    <LabelerName>Novitium Pharma LLC</LabelerName>
    <SubstanceName>NITISINONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-11-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190826</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70954-014-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-014-10) </PackageDescription>
    <NDC11Code>70954-0014-10</NDC11Code>
    <ProductNDC>70954-014</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiothixene</ProprietaryName>
    <NonProprietaryName>Thiothixene</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211642</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>THIOTHIXENE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4- methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide  functional group is bonded to  the  thioxanthene  nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Red No. 28 and the 2 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains the following: ammonia solution, black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-015-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-015-10) </PackageDescription>
    <NDC11Code>70954-0015-10</NDC11Code>
    <ProductNDC>70954-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiothixene</ProprietaryName>
    <NonProprietaryName>Thiothixene</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211642</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>THIOTHIXENE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4- methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide  functional group is bonded to  the  thioxanthene  nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Red No. 28 and the 2 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains the following: ammonia solution, black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-016-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-016-10) </PackageDescription>
    <NDC11Code>70954-0016-10</NDC11Code>
    <ProductNDC>70954-016</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiothixene</ProprietaryName>
    <NonProprietaryName>Thiothixene</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211642</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>THIOTHIXENE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4- methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide  functional group is bonded to  the  thioxanthene  nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Red No. 28 and the 2 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains the following: ammonia solution, black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-017-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-017-10) </PackageDescription>
    <NDC11Code>70954-0017-10</NDC11Code>
    <ProductNDC>70954-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Thiothixene</ProprietaryName>
    <NonProprietaryName>Thiothixene</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211642</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>THIOTHIXENE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
    <Description>Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4- methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide. It may be represented by the following structural formula. The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide  functional group is bonded to  the  thioxanthene  nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each of the empty gelatin capsules contains FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Red No. 28 and the 2 mg empty gelatin capsules contain D&amp;C Yellow No. 10. The imprinting ink contains the following: ammonia solution, black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-019-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-019-10) </PackageDescription>
    <NDC11Code>70954-0019-10</NDC11Code>
    <ProductNDC>70954-019</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210971</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Molecular formula C19H21N5O4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Yellow No. 10 and FD&amp;C Green No. 3; the 2 mg empty gelatin capsules contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1 and FD&amp;C Red No. 40; and the 5 mg empty gelatin capsules contain FD&amp;C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-020-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-020-10) </PackageDescription>
    <NDC11Code>70954-0020-10</NDC11Code>
    <ProductNDC>70954-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210971</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Molecular formula C19H21N5O4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Yellow No. 10 and FD&amp;C Green No. 3; the 2 mg empty gelatin capsules contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1 and FD&amp;C Red No. 40; and the 5 mg empty gelatin capsules contain FD&amp;C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-021-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-021-10) </PackageDescription>
    <NDC11Code>70954-0021-10</NDC11Code>
    <ProductNDC>70954-021</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181003</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210971</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181003</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:Molecular formula C19H21N5O4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Yellow No. 10 and FD&amp;C Green No. 3; the 2 mg empty gelatin capsules contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1 and FD&amp;C Red No. 40; and the 5 mg empty gelatin capsules contain FD&amp;C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-025-10</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70954-025-10) </PackageDescription>
    <NDC11Code>70954-0025-10</NDC11Code>
    <ProductNDC>70954-025</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Macitentan</ProprietaryName>
    <NonProprietaryName>Macitentan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211120</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>MACITENTAN</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH (1.1).</IndicationAndUsage>
    <Description>Macitentan is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecular weight of 588.27. Macitentan is achiral and has the following structural formula. Macitentan is a white to off-white color solid that is soluble in dichloromethane, ethyl acetate and practically insoluble in water. In the solid state macitentan is very stable, is not hygroscopic, and is not light sensitive. Macitentan tablets are available as a 10 mg film-coated tablet for once daily oral administration. The tablets include the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone. The tablets are film-coated with a coating material containing polyvinyl alcohol, soya lecithin, talc, titanium dioxide, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-040-10</NDCCode>
    <PackageDescription>1 PACKET in 1 CARTON (70954-040-10)  / 1 GRANULE, FOR SOLUTION in 1 PACKET</PackageDescription>
    <NDC11Code>70954-0040-10</NDC11Code>
    <ProductNDC>70954-040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
    <NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName>
    <DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20261001</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210426</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20261001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fosfomycin Tromethamine Granules for Oral Solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine Granules for Oral Solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES section).</IndicationAndUsage>
    <Description>Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, USP, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white to off white granules consisting of 5.631 grams of fosfomycin tromethamine, USP (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, sodium saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, USP, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl) phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its molecular formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-041-10</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (70954-041-10) </PackageDescription>
    <NDC11Code>70954-0041-10</NDC11Code>
    <ProductNDC>70954-041</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rifabutin</ProprietaryName>
    <NonProprietaryName>Rifabutin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215041</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>RIFABUTIN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Rifamycin Antimycobacterial [EPC], Rifamycins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.</IndicationAndUsage>
    <Description>Rifabutin Capsules, USP for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule along with the inactive ingredients, microcrystalline cellulose, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate. The hard gelatin capsule contains titanium dioxide, red iron oxide, gelatin, sodium lauryl sulfate and purified water. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S,12E,14S,15R, 16S,17R,18R,19R,20S,21S,22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy- 7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H- furo[2',3':7,8]naphth[1,2-d] imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure. Rifabutin is a red-violet powder soluble in methanol, slightly soluble in ethanol, and slightly soluble in water (0.21 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water). FDA approved dissolution method differs from the current USP monograph dissolution method.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-051-10</NDCCode>
    <PackageDescription>237 mL in 1 BOTTLE (70954-051-10) </PackageDescription>
    <NDC11Code>70954-0051-10</NDC11Code>
    <ProductNDC>70954-051</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Felbamate</ProprietaryName>
    <NonProprietaryName>Felbamate</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220715</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211333</ApplicationNumber>
    <LabelerName>Novitium Pharma LLC</LabelerName>
    <SubstanceName>FELBAMATE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings). Felbamate oral suspension is recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgement, felbamate oral suspension can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
    <Description>Felbamate, USP is an antiepileptic available as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate, USP’s molecular formula is C11H14N2O4; its structural formula is. The inactive ingredients for Felbamate Oral Suspension, USP 600 mg/5 mL are noncrystallizing sorbitol solution, microcrystalline cellulose and carboxymethylcellulose sodium, glycerin, methylparaben, propylparaben, polysorbate 80, simethicone emulsion, saccharin sodium monohydrate, bubblegum flavor (contains arabic gum, and natural and artificial flavor), FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, and purified water.</Description>
  </NDC>
  <NDC>
    <NDCCode>70954-052-10</NDCCode>
    <PackageDescription>50 TABLET in 1 BOTTLE (70954-052-10) </PackageDescription>
    <NDC11Code>70954-0052-10</NDC11Code>
    <ProductNDC>70954-052</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217881</ApplicationNumber>
    <LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250505</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Non suppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosus. Systemic dermatomyositis (polymyositis). Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitis. Serum sickness. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Iritis and iridocyclitis. Chorioretinitis. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Hydrocortisone Tablets, USP contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone, USP is white to practically white, odorless, crystalline powder with a melting point of about 215°C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone Tablets, USP are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of Hydrocortisone, USP. Inactive ingredients: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. FDA approved dissolution test and specifications differs from the USP.</Description>
  </NDC>
</NDCList>