RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>61919-628-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (61919-628-60) </PackageDescription>
    <NDC11Code>61919-0628-60</NDC11Code>
    <ProductNDC>61919-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091625</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure]. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-628-21</NDCCode>
    <PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE (61919-628-21) </PackageDescription>
    <NDC11Code>61919-0628-21</NDC11Code>
    <ProductNDC>61919-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091625</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure]. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-628-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (61919-628-30) </PackageDescription>
    <NDC11Code>61919-0628-30</NDC11Code>
    <ProductNDC>61919-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190329</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091625</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190329</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure]. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-628-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (61919-628-90) </PackageDescription>
    <NDC11Code>61919-0628-90</NDC11Code>
    <ProductNDC>61919-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091625</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.</IndicationAndUsage>
    <Description>Ibuprofen tablets contain the active ingredient ibuprofen, which is (±)-2-(p-isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (&lt;1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: [ibuprofen-structure]. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 400 mg, 600 mg and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 2910, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, povidone k-90, sodium lauryl sulphate, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>10237-628-60</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10237-628-60)  &gt; 170 g in 1 TUBE</PackageDescription>
    <NDC11Code>10237-0628-60</NDC11Code>
    <ProductNDC>10237-628</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aim Tartar Control</ProprietaryName>
    <ProprietaryNameSuffix>Plus Mouthwash And Whitening</ProprietaryNameSuffix>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>GEL, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20040301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Church &amp; Dwight Co., Inc.</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.4</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>37205-628-60</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (37205-628-60)  &gt; 20 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
    <NDC11Code>37205-0628-60</NDC11Code>
    <ProductNDC>37205-628</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Leader Mucus Er</ProprietaryName>
    <NonProprietaryName>Guaifenesin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130319</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078912</ApplicationNumber>
    <LabelerName>Cardinal Health</LabelerName>
    <SubstanceName>GUAIFENESIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-30</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>42291-628-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (42291-628-60) </PackageDescription>
    <NDC11Code>42291-0628-60</NDC11Code>
    <ProductNDC>42291-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Naproxen</ProprietaryName>
    <NonProprietaryName>Naproxen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075927</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>NAPROXEN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Naproxen tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
    <Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid. Naproxen, USP has the following structures. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. Naproxen, USP is available as white tablets containing 250 mg of naproxen, USP white tablets containing 375 mg of naproxen, USP and white tablets containing 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>43744-628-60</NDCCode>
    <PackageDescription>750 g in 1 DRUM (43744-628-60)</PackageDescription>
    <NDC11Code>43744-0628-60</NDC11Code>
    <ProductNDC>43744-628</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Monobenzone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20121001</StartMarketingDate>
    <EndMarketingDate>20130624</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>CBSCHEM LIMITED</LabelerName>
    <SubstanceName>MONOBENZONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55700-628-60</NDCCode>
    <PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-60) </PackageDescription>
    <NDC11Code>55700-0628-60</NDC11Code>
    <ProductNDC>55700-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180518</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>Quality Care Products LLC</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&amp;C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>66215-628-20</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (66215-628-20)  *  1 BOTTLE in 1 CARTON / 140 TABLET, COATED in 1 BOTTLE *  1 BOTTLE in 1 CARTON / 60 TABLET, COATED in 1 BOTTLE</PackageDescription>
    <NDC11Code>66215-0628-20</NDC11Code>
    <ProductNDC>66215-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Uptravi Titration Pack</ProprietaryName>
    <NonProprietaryName>Selexipag</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20151221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA207947</ApplicationNumber>
    <LabelerName>Actelion Pharmaceuticals US, Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): 1 In adults to delay disease progression and reduce the risk of hospitalization for PAH. (1.1), 2 In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. (1.1).</IndicationAndUsage>
    <Description>UPTRAVI contains selexipag, a prostacyclin receptor agonist. The chemical name of selexipag is 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide. It has a molecular formula of C26H32N4O4S and a molecular weight of 496.62. Selexipag has the following structural formula. Selexipag is a pale yellow crystalline powder that is practically insoluble in water. In the solid state selexipag is very stable, is not hygroscopic, and is not light sensitive. UPTRAVI® (selexipag) tablets: depending on the dose strength, each round film-coated tablet for oral administration contains 100, 150, 200, 400, 600, 800, 1,000, 1,200, 1,400, or 1,600 mcg of selexipag. The tablets include the following inactive ingredients: corn starch, D-mannitol, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, and magnesium stearate. The tablets are film coated with a coating material containing carnauba wax, hypromellose, propylene glycol, titanium dioxide, along with mixtures of iron oxide black, iron oxide red and/or iron oxide yellow. The coating material of the 100 mcg and 150 mcg tablets also contains talc. UPTRAVI® (selexipag) for injection: contains 1,800 mcg of selexipag per vial. UPTRAVI for injection includes the following inactive ingredients: glycine (180 mg), phosphoric acid (3.53 mg), polysorbate 20 (10.8 mg) and sodium hydroxide (for pH adjustment). UPTRAVI for injection is provided in 10 mL Type I clear glass vials closed by a stopper and tear-off aluminum seal.</Description>
  </NDC>
  <NDC>
    <NDCCode>69953-628-60</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (69953-628-60)  / 1 mg in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>69953-0628-60</NDC11Code>
    <ProductNDC>69953-628</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Postday One-step</ProprietaryName>
    <NonProprietaryName>Levonorgestrel</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230116</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205329</ApplicationNumber>
    <LabelerName>Rapha Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVONORGESTREL</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1.5mg</StrengthUnit>
    <Pharm_Classes>Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230116</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71610-628-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71610-628-60) </PackageDescription>
    <NDC11Code>71610-0628-60</NDC11Code>
    <ProductNDC>71610-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxazosin</ProprietaryName>
    <NonProprietaryName>Doxazosin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20211019</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA019668</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>DOXAZOSIN MESYLATE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-02-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Doxazosin is an alpha1 adrenergic antagonist indicated for: 1 Signs and symptoms of Benign Prostatic Hyperplasia (BPH), 2 Treatment of Hypertension.</IndicationAndUsage>
    <Description>Doxazosin is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of Doxazosin is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for Doxazosin is C23H25N5O5 ∙ CH4O3S and the molecular weight is 547.6. It has the following structure. Doxazosin is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin tablet is available as colored tablets for oral use and contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) and 8 mg (green or white) of doxazosin as the free base. The inactive ingredients for all tablets are microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg yellow tablet contains D &amp; C yellow 10 and FD &amp; C yellow 6; the 4 mg orange tablet contains FD &amp; C yellow 6; the 8 mg green tablet contains FD &amp; C blue 2 and D &amp; C yellow 10.</Description>
  </NDC>
  <NDC>
    <NDCCode>72644-628-02</NDCCode>
    <PackageDescription>60 mL in 1 BOTTLE (72644-628-02) </PackageDescription>
    <NDC11Code>72644-0628-02</NDC11Code>
    <ProductNDC>72644-628</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Senegence Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200707</StartMarketingDate>
    <EndMarketingDate>20220707</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>SGII, Inc</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-12-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200707</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220707</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76420-628-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (76420-628-60) </PackageDescription>
    <NDC11Code>76420-0628-60</NDC11Code>
    <ProductNDC>76420-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ramelteon</ProprietaryName>
    <NonProprietaryName>Ramelteon</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190723</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211567</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>RAMELTEON</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-11-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies ( 14)] .</IndicationAndUsage>
    <Description>Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1, 6, 7, 8  tetrahydro-2 H-indeno-[5, 4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an molecular formula of C 16H 21NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is a white to cream color powder and it is freely soluble in methanol and practically insoluble in water. Each film-coated tablet contains 8 mg ramelteon and contains following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch (botanical source: maize), sodium stearyl fumarate, titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-0522-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60) </PackageDescription>
    <NDC11Code>00074-0522-60</NDC11Code>
    <ProductNDC>0074-0522</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kaletra</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100618</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021906</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>100; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100618</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
    <Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Yellow or red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pale yellow or pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
  </NDC>
  <NDC>
    <NDCCode>0074-3008-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60) </PackageDescription>
    <NDC11Code>00074-3008-60</NDC11Code>
    <ProductNDC>0074-3008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kaletra</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200408</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021906</ApplicationNumber>
    <LabelerName>AbbVie Inc.</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>100; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: : 1 Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology (12.4)]. .</IndicationAndUsage>
    <Description>KALETRA is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula:. Ritonavir is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula:. KALETRA tablets are available for oral administration in two strengths: : 1 Red tablets containing 200 mg of lopinavir and 50 mg of ritonavir, 2 Pink tablets containing 100 mg of lopinavir and 25 mg of ritonavir.</Description>
  </NDC>
  <NDC>
    <NDCCode>23155-628-01</NDCCode>
    <PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-628-01) </PackageDescription>
    <NDC11Code>23155-0628-01</NDC11Code>
    <ProductNDC>23155-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Isosorbide Mononitrate</ProprietaryName>
    <NonProprietaryName>Isosorbide Mononitrate</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181115</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210822</ApplicationNumber>
    <LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ISOSORBIDE MONONITRATE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20181115</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Isosorbide Mononitrate Extended-Release Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.</IndicationAndUsage>
    <Description>Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Each tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, ISMN 30 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate. ISMN 60 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, yellow iron oxide. ISMN 120 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and talc. The molecular formula of ISMN is C6H9NO6 and the molecular weight is 191.14. The chemical name for ISMN is: 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula. ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. Isosorbide Mononitrate Extended-Release 120mg Tablets, USP meets USP Dissolution Test 7. FDA approved dissolution acceptance criteria for Isosorbide Mononitrate Extended-Release 30mg and 60mg Tablets, USP differ from that of the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-556-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-556-60) </PackageDescription>
    <NDC11Code>31722-0556-60</NDC11Code>
    <ProductNDC>31722-556</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210607</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091677</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>200; 50</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use:   Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology  (12.4)].</IndicationAndUsage>
    <Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths:  Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP  Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-603-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-603-60) </PackageDescription>
    <NDC11Code>31722-0603-60</NDC11Code>
    <ProductNDC>31722-603</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210607</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091677</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>100; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-06-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210607</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use:   Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology  (12.4)].</IndicationAndUsage>
    <Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths:  Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP  Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-163-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-163-09) </PackageDescription>
    <NDC11Code>33342-0163-09</NDC11Code>
    <ProductNDC>33342-163</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204739</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>100; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV1 infection in adults and pediatric patients 14 days and older. Limitations of Use:Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir  [see Microbiology (12.4)].</IndicationAndUsage>
    <Description>Lopinavir and ritonavir tablets are a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir, USP is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula. Ritonavir, USP is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula. Lopinavir and ritonavir tablets, USP are available for oral administration in two strengths: : 1 Yellow tablets containing 200 mg of lopinavir and 50 mg of ritonavir , 2 Pale yellow tablets containing 100 mg of lopinavir and 25 mg of ritonavir. .</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-164-09</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-164-09) </PackageDescription>
    <NDC11Code>33342-0164-09</NDC11Code>
    <ProductNDC>33342-164</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240725</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204739</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>200; 50</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV1 infection in adults and pediatric patients 14 days and older. Limitations of Use:Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir  [see Microbiology (12.4)].</IndicationAndUsage>
    <Description>Lopinavir and ritonavir tablets are a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir, USP is chemically designated as [1S-[1R*,(R*), 3R*, 4R*]]-N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.80. Lopinavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Lopinavir has the following structural formula. Ritonavir, USP is chemically designated as 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12-tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir is a white to light tan powder. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water. Ritonavir has the following structural formula. Lopinavir and ritonavir tablets, USP are available for oral administration in two strengths: : 1 Yellow tablets containing 200 mg of lopinavir and 50 mg of ritonavir , 2 Pale yellow tablets containing 100 mg of lopinavir and 25 mg of ritonavir. .</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-933-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (42385-933-60) </PackageDescription>
    <NDC11Code>42385-0933-60</NDC11Code>
    <ProductNDC>42385-933</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
    <NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213857</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
    <StrengthNumber>100; 25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV- 1 infection in adults and pediatric patients 14 days and older. Limitations of Use: 1 Genotypic or phenotypic testing and/or treatment history should guide the use of  lopinavir and ritonavir. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see Microbiology (12.4)].</IndicationAndUsage>
    <Description>Lopinavir and ritonavir tablets, USP are a co-formulation of lopinavir USP and ritonavir USP. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir tablets, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir USP is chemically designated as [1S-[1R*,(R*),3R*,4R*]]-N-[4-[[(2,6- dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-α-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide. Its molecular formula is C37H48N4O5, and its molecular weight is 628.8 g/mol. Lopinavir USP is a white to off-white color solid. It is freely soluble in methanol, soluble in isopropyl alcohol and practically insoluble in water. Lopinavir USP has the following structural formula. Ritonavir USP is chemically designated as 2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-di-oxo-8,11-bis(phenylmethyl)-5-thiazolylmethylester[5S-(5R*,8R*,10R*,11R*)]-. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.94 g/mol. Ritonavir USP is a white or almost white solid. It is freely soluble in methanol and in dichloromethane; very slightly soluble in acetonitrile; practically insoluble in water. Ritonavir USP has the following structural formula. Lopinavir and ritonavir tablets, USP are available for oral administration in two strengths: : 1 Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP., 2 Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-628-30</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-30) </PackageDescription>
    <NDC11Code>55700-0628-30</NDC11Code>
    <ProductNDC>55700-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180518</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>Quality Care Products LLC</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&amp;C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-628-90</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55700-628-90) </PackageDescription>
    <NDC11Code>55700-0628-90</NDC11Code>
    <ProductNDC>55700-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180518</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208706</ApplicationNumber>
    <LabelerName>Quality Care Products LLC</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220322</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Generalized Anxiety Disorder [see Clinical Studies (14.2)]. , 3 Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]. , 4 Chronic Musculoskeletal Pain [see Clinical Studies (14.5)].</IndicationAndUsage>
    <Description>Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is.          Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.          Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.          The capsule shell contains gelatin, FD&amp;C Blue No. 2, titanium dioxide, and sodium lauryl sulfate.           For 20 mg, 30 mg  (body &amp; cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.          For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.          USP Assay &amp; Organic Impurities test pending.</Description>
  </NDC>
  <NDC>
    <NDCCode>70515-628-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70515-628-30) </PackageDescription>
    <NDC11Code>70515-0628-30</NDC11Code>
    <ProductNDC>70515-628</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Altoprev</ProprietaryName>
    <NonProprietaryName>Lovastatin</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160501</StartMarketingDate>
    <EndMarketingDate>20251130</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021316</ApplicationNumber>
    <LabelerName>Covis Pharma US, Inc</LabelerName>
    <SubstanceName>LOVASTATIN</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160501</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Altoprev is indicated: 1 To reduce the risk of myocardial infarction, unstable angina, and coronary revascularization procedures in adults at high risk for coronary heart disease., 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of coronary atherosclerosis in adults with coronary heart disease., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). .</IndicationAndUsage>
    <Description>Altoprev (lovastatin extended-release) tablets are an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase (statin) isolated from a strain of Aspergillus terreus. Lovastatin is [1 S –[1α(R*),3α,7β,8β(2 S*,4 S*),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Altoprev extended-release tablets for oral use contain 20 mg, 40 mg, or 60 mg of lovastatin. In addition, each tablet contains the following inactive ingredients: acetyltributyl citrate; butylated hydroxy anisole; candelilla wax; cellulose acetate; confectioner’s sugar (contains corn starch); F D &amp; C yellow # 6; glyceryl monostearate; hypromellose; hypromellose phthalate; lactose; methacrylic acid copolymer, type B; polyethylene glycols (PEG 400, PEG 8000); polyethylene oxides; polysorbate 80; propylene glycol; silicon dioxide; sodium chloride; sodium lauryl sulfate; synthetic black iron oxide; red iron oxide; talc; titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-002-60</NDCCode>
    <PackageDescription>60 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (61919-002-60)</PackageDescription>
    <NDC11Code>61919-0002-60</NDC11Code>
    <ProductNDC>61919-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022370</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.</IndicationAndUsage>
    <Description>Tramadol Hydrochloride Extended-Release (tramadol hydrochloride) capsules is a centrally acting synthetic analgesic in an extended-release oral formulation. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. Figure 1. The molecular weight of tramadol hydrochloride is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Extended-Release capsules contain a total dose of tramadol HCl 100, 200 and 300 mg in a combination of immediate-release and extended-release components. Tramadol Hydrochloride Extended-Release capsules are white in color. Inactive ingredients include gelatin, titanium dioxide, shellac, yellow iron oxide, lactose monohydrate 200 mesh, microcrystalline cellulose, povidone K30, corn starch, sodium starch glycolate, magnesium stearate, sucrose stearate, hypromellose, talc, polysorbate 80, Eudragit NE 30D, and simethicone emulsion.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-005-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (61919-005-60) </PackageDescription>
    <NDC11Code>61919-0005-60</NDC11Code>
    <ProductNDC>61919-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074112</ApplicationNumber>
    <LabelerName>Direct Rx</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190916</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Anxiety Disorders Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder Alprazolam is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD &amp; C Yellow #6 Aluminum Lake, and the 1 mg also contains FD &amp; C Blue #2 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-006-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (61919-006-60)</PackageDescription>
    <NDC11Code>61919-0006-60</NDC11Code>
    <ProductNDC>61919-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078491</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC],Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Anxiety Disorders. Alprazolam tablets are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam tablets. Panic Disorder. Alprazolam tablets are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam tablets by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Alprazolam Tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo[4,3-α][1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam tablets, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Colloidal silicon dioxide, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium benzoate and sodium starch glycolate. In addition, the 0.5 mg tablet contains FD&amp;C Yellow No. 6 Aluminum Lake and the 1 mg tablet contains FD&amp;C Blue No. 1 Aluminum Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-008-60</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (61919-008-60)</PackageDescription>
    <NDC11Code>61919-0008-60</NDC11Code>
    <ProductNDC>61919-008</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Promethazine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Promethazine Hydrochloride Tablet</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091179</ApplicationNumber>
    <LabelerName>Direct Rx</LabelerName>
    <SubstanceName>PROMETHAZINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phenothiazine [EPC],Phenothiazines [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Promethazine hydrochloride tablets are useful for:Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.Preoperative, postoperative and obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.Sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.</IndicationAndUsage>
    <Description>Rx only. DESCRIPTION. Promethazine Hydrochloride, a phenothiazine derivative, is designated chemically as 10- [2-(Dimethylamino)propyl]phenothiazine monohydochloride and has the following structural formula. Promethazine hydrochloride is a racemic compound; the empirical formula is C17H20N2S HCl and its molecular weight is 320.88. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Each tablet for oral administration contains 12.5 mg, 25 mg or 50 mg promethazine hydrochloride, USP. The inactive ingredients include: lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The 50 mg also contains D&amp;C Red # 27 Lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-011-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (61919-011-60)</PackageDescription>
    <NDC11Code>61919-0011-60</NDC11Code>
    <ProductNDC>61919-011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040218</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
    <Description>Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23NHCl, and its structural formula is. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&amp;C blue #1 lake. The 25 mg tablets also contain D&amp;C yellow #10 lake and FD&amp;C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&amp;C yellow #6 lake. The 100 mg tablets also contain D&amp;C red #33 lake and FD&amp;C red #40 lake. The 150 mg tablets also contain FD&amp;C blue #2 lake and FD&amp;C yellow #6 lake.</Description>
  </NDC>
</NDCList>