RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>42385-951-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (42385-951-11) </PackageDescription>
    <NDC11Code>42385-0951-11</NDC11Code>
    <ProductNDC>42385-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211122</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sucrose. In addition, individual tablets contain:. 48 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake and FD &amp; C yellow #6/sunset yellow FCF aluminium lake. 145 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-951-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (42385-951-30) </PackageDescription>
    <NDC11Code>42385-0951-30</NDC11Code>
    <ProductNDC>42385-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211122</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sucrose. In addition, individual tablets contain:. 48 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake and FD &amp; C yellow #6/sunset yellow FCF aluminium lake. 145 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-951-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (42385-951-90) </PackageDescription>
    <NDC11Code>42385-0951-90</NDC11Code>
    <ProductNDC>42385-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211122</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>145</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sucrose. In addition, individual tablets contain:. 48 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake and FD &amp; C yellow #6/sunset yellow FCF aluminium lake. 145 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>10202-951-37</NDCCode>
    <PackageDescription>156 g in 1 CAN (10202-951-37) </PackageDescription>
    <NDC11Code>10202-0951-37</NDC11Code>
    <ProductNDC>10202-951</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>7 Select Sport Spf 30</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181217</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>7-11</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>30; 100; 50; 20; 40</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see ​Directions​), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>37803-951-11</NDCCode>
    <PackageDescription>120 g in 1 CONTAINER (37803-951-11)</PackageDescription>
    <NDC11Code>37803-0951-11</NDC11Code>
    <ProductNDC>37803-951</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Baclofen</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <StartMarketingDate>20150407</StartMarketingDate>
    <EndMarketingDate>20150407</EndMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Apotheca Supply, Inc.</LabelerName>
    <SubstanceName>BACLOFEN</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20150407</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60687-951-21</NDCCode>
    <PackageDescription>30 BLISTER PACK in 1 CARTON (60687-951-21)  / 1 CAPSULE in 1 BLISTER PACK (60687-951-11) </PackageDescription>
    <NDC11Code>60687-0951-21</NDC11Code>
    <ProductNDC>60687-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lisdexamfetamine Dimesylate</ProprietaryName>
    <NonProprietaryName>Lisdexamfetamine Dimesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217442</ApplicationNumber>
    <LabelerName>American Health Packaging</LabelerName>
    <SubstanceName>LISDEXAMFETAMINE DIMESYLATE</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lisdexamfetamine dimesylate capsules are indicated for the treatment of: 1 Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [seeClinical Studies (14.1)], 2 Moderate to severe binge eating disorder (BED) in adults [seeClinical Studies (14.2)].</IndicationAndUsage>
    <Description>Lisdexamfetamine dimesylate, a CNS stimulant, is for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 17H 33N 3O 7S 2, which corresponds to a molecular weight of 455.59. The chemical structure is:. Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (986 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine). Inactive ingredients: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. Each strength capsule also contains colorant ingredients in the capsule shell as follows. 10 mg: FD&amp;C Red No. 3 20 mg: Iron Oxide Yellow 30 mg: FD&amp;C Red No. 3 and FD&amp;C Yellow No. 6 40 mg: FD&amp;C Red No. 3 and FD&amp;C Blue No. 1 50 mg: FD&amp;C Red No. 3 and FD&amp;C Blue No. 1 60 mg: FD&amp;C Red No. 3 and FD&amp;C Blue No. 1 70 mg: FD&amp;C Blue No. 1 and D&amp;C Red 28.</Description>
  </NDC>
  <NDC>
    <NDCCode>62207-951-11</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (62207-951-11) </PackageDescription>
    <NDC11Code>62207-0951-11</NDC11Code>
    <ProductNDC>62207-951</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20170811</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Granules India Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>11-AUG-17</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>63304-951-17</NDCCode>
    <PackageDescription>10 POUCH in 1 BOX, UNIT-DOSE (63304-951-17)  &gt; 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-951-11) </PackageDescription>
    <NDC11Code>63304-0951-17</NDC11Code>
    <ProductNDC>63304-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Risperidone</ProprietaryName>
    <NonProprietaryName>Risperidone</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100806</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077542</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>RISPERIDONE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-07-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Risperidone orally disintegrating tablet is an atypical antipsychotic indicated for: 1 Treatment of schizophrenia (1.1), 2 As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder (1.2), 3 Treatment of irritability associated with autistic disorder (1.3).</IndicationAndUsage>
    <Description>Risperidone orally disintegrating tablets contain risperidone, USP an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)‑1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H- pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:. Risperidone, USP is a white to off white powder. It is practically insoluble in water, soluble in methylene chloride, and sparingly soluble in alcohol. Risperidone orally disintegrating tablets are for oral administration and available as 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg pink tablets. Inactive ingredients are aspartame*, colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, flavor peppermint, low substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, menthol, saccharin sodium and talc. *[see Patient Counseling Information (17.7)].</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-951-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (71205-951-11) </PackageDescription>
    <NDC11Code>71205-0951-11</NDC11Code>
    <ProductNDC>71205-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Warfarin Sodium</ProprietaryName>
    <NonProprietaryName>Warfarin Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090935</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>WARFARIN SODIUM</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Warfarin sodium tablets are indicated for: : 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
    <Description>Warfarin sodium, USP is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α- acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is C19H15NaO4, and its structural formula is represented by the following. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet, USP intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, hydroxypropyl cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&amp;C Red #30 aluminum lake 2 mg tablet contains: FD&amp;C Red #40 aluminum lake and FD&amp;C Blue#2 2.5 mg tablet contains: D&amp;C Yellow # 10 aluminum lake and FD&amp;C Blue#2 3 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake, FD&amp;C Blue#2 and FD&amp;C Red # 40 aluminum lake 4 mg tablet contains: FD&amp;C Blue#2 5 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake 6 mg tablet contains: FD&amp;C Yellow # 6 aluminum lake and FD&amp;C Blue #2 7.5 mg tablet contains: D&amp;C Yellow # 10 aluminum lake and FD&amp;C Yellow # 6 aluminum lake 10 mg tablet is dye free.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-951-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (82804-951-11) </PackageDescription>
    <NDC11Code>82804-0951-11</NDC11Code>
    <ProductNDC>82804-951</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075563</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>120</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sotalol hydrochloride tablets are an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1) , 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
    <Description>Sotalol hydrochloride tablets, USP contain sotalol hydrochloride USP, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride tablets, USP are supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3S●HCl and is represented by the following structural formula. Sotalol hydrochloride tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, FD&amp;C blue color #2 (aluminum lake, conc.), lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-935-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11) </PackageDescription>
    <NDC11Code>42385-0935-11</NDC11Code>
    <ProductNDC>42385-935</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210606</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>54</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake, FD &amp; C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-936-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-936-11) </PackageDescription>
    <NDC11Code>42385-0936-11</NDC11Code>
    <ProductNDC>42385-936</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200113</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210606</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200113</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒC. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake, FD &amp; C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-940-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-940-11) </PackageDescription>
    <NDC11Code>42385-0940-11</NDC11Code>
    <ProductNDC>42385-940</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-941-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-941-11) </PackageDescription>
    <NDC11Code>42385-0941-11</NDC11Code>
    <ProductNDC>42385-941</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-942-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-942-11) </PackageDescription>
    <NDC11Code>42385-0942-11</NDC11Code>
    <ProductNDC>42385-942</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-943-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-943-11) </PackageDescription>
    <NDC11Code>42385-0943-11</NDC11Code>
    <ProductNDC>42385-943</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atorvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214513</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atorvastatin calcium tablets are indicated.  To reduce the risk of:      o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD      o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD      o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:     o Adults with primary hyperlipidemia.     o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).   As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).   As an adjunct to diet for the treatment of adults with:     o Primary dysbetalipoproteinemia     o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium is calcium(βR,δR)-2-(p-fluorophenyl)-β,δ-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2). The molecular formula of atorvastatin calcium is C66H68CaF2N4O103H2O and its molecular weight is 1,209.41. Its structural formula is:. Atorvastatin calcium USP is a white to off white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium USP is insoluble to very slightly soluble in distilled water, in pH 7.4 phosphate buffer, and in acetonitrile; very slightly soluble to soluble in alcohol (99.9%); and soluble to freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.36 mg, 20.72 mg, 41.44 mg, or 82.88 mg atorvastatin calcium anhydrous) and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide) and polysorbate 80. Meets USP Dissolution Test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-944-11</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-11) </PackageDescription>
    <NDC11Code>42385-0944-11</NDC11Code>
    <ProductNDC>42385-944</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid Delayed-release</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200824</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211626</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD &amp; C blue 1, FD &amp; C red 3, FD &amp; C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-945-11</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-945-11) </PackageDescription>
    <NDC11Code>42385-0945-11</NDC11Code>
    <ProductNDC>42385-945</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid Delayed-release</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200824</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211626</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>135</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to: 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD &amp; C blue 1, FD &amp; C red 3, FD &amp; C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-947-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-947-11) </PackageDescription>
    <NDC11Code>42385-0947-11</NDC11Code>
    <ProductNDC>42385-947</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-948-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-948-11) </PackageDescription>
    <NDC11Code>42385-0948-11</NDC11Code>
    <ProductNDC>42385-948</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>850</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-949-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-949-11) </PackageDescription>
    <NDC11Code>42385-0949-11</NDC11Code>
    <ProductNDC>42385-949</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210517</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209882</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5  HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and povidone. In addition, the tablet coating material of 500 mg, 850 mg and 1,000 mg tablets contain hypromellose, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide and artificial blackberry flavor.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-950-11</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (42385-950-11) </PackageDescription>
    <NDC11Code>42385-0950-11</NDC11Code>
    <ProductNDC>42385-950</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200318</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211122</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>48</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200318</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate tablets are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.1). , 2 For treatment of adult patients with severe hypertriglyceridemia (  1.2).  .</IndicationAndUsage>
    <Description>Fenofibrate tablets, USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sucrose. In addition, individual tablets contain:. 48 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, D&amp;C yellow #10 aluminum lake, FD &amp; C blue #2/indigo carmine aluminum lake and FD &amp; C yellow #6/sunset yellow FCF aluminium lake. 145 mg tablets. lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-971-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11) </PackageDescription>
    <NDC11Code>42385-0971-11</NDC11Code>
    <ProductNDC>42385-971</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
    <NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230306</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210959</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230306</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hydroxychloroquine sulfate tablets are an antimalarial and antirheumatic indicated for the:  Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1)  Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1)  Treatment of rheumatoid arthritis in adults. (1.2)  Treatment of systemic lupus erythematosus in adults. (1.3)  Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1): Hydroxychloroquine sulfate tablets are not recommended for the:  Treatment of complicated malaria.   Treatment of chloroquine or hydroxychloroquine-resistant strains ofPlasmodium species.  Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.  Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.  Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
    <Description>Hydroxychloroquine is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4-quinolyl) amino]pentyl] ethylamino] ethanol sulfate (1:1) with the molecular formula C18H26ClN3OH2SO4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate USP is a white or off-white to slightly yellowish color powder, freely soluble in water and practically insoluble in ethanol. Hydroxychloroquine sulfate tablets, USP for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: lactose monohydrate, magnesium stearate, maize starch and povidone. The film coating contains polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-972-11</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42385-972-11) </PackageDescription>
    <NDC11Code>42385-0972-11</NDC11Code>
    <ProductNDC>42385-972</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217546</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP and gabapentin tablets, USP is gabapentin USP, which has the chemical name 1-(Aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin USP and the following inactive ingredients: mannitol, pregelatinized starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains iron oxide yellow and 400 mg also contains iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing FD&amp;C blue no. 2 aluminum lake and shellac. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, maize starch 5%, microcrystalline cellulose, magnesium stearate and poloxamer P407. In addition, the film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, titanium dioxide and talc. Gabapentin tablets, USP meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-973-11</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42385-973-11) </PackageDescription>
    <NDC11Code>42385-0973-11</NDC11Code>
    <ProductNDC>42385-973</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217546</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP and gabapentin tablets, USP is gabapentin USP, which has the chemical name 1-(Aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin USP and the following inactive ingredients: mannitol, pregelatinized starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains iron oxide yellow and 400 mg also contains iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing FD&amp;C blue no. 2 aluminum lake and shellac. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, maize starch 5%, microcrystalline cellulose, magnesium stearate and poloxamer P407. In addition, the film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, titanium dioxide and talc. Gabapentin tablets, USP meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-974-11</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42385-974-11) </PackageDescription>
    <NDC11Code>42385-0974-11</NDC11Code>
    <ProductNDC>42385-974</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217546</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP and gabapentin tablets, USP is gabapentin USP, which has the chemical name 1-(Aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin USP and the following inactive ingredients: mannitol, pregelatinized starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains iron oxide yellow and 400 mg also contains iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing FD&amp;C blue no. 2 aluminum lake and shellac. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, maize starch 5%, microcrystalline cellulose, magnesium stearate and poloxamer P407. In addition, the film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, titanium dioxide and talc. Gabapentin tablets, USP meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-977-11</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-11) </PackageDescription>
    <NDC11Code>42385-0977-11</NDC11Code>
    <ProductNDC>42385-977</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217631</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethyl imidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white or almost white crystals with a molecular formula of C4H11N5HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in 96% ethanol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose, and magnesium stearate. Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 11.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-978-11</NDCCode>
    <PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-978-11) </PackageDescription>
    <NDC11Code>42385-0978-11</NDC11Code>
    <ProductNDC>42385-978</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metformin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217631</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231006</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
    <Description>Metformin hydrochloride extended-release tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethyl imidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride, USP is a white or almost white crystals with a molecular formula of C4H11N5HCl and a molecular weight of 165.62. It is freely soluble in water, slightly soluble in 96% ethanol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose, and magnesium stearate. Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 11.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-979-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-979-11) </PackageDescription>
    <NDC11Code>42385-0979-11</NDC11Code>
    <ProductNDC>42385-979</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217965</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP and gabapentin tablets, USP is gabapentin USP, which has the chemical name 1-(Aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin USP and the following inactive ingredients: mannitol, pregelatinized starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains iron oxide yellow and 400 mg also contains iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing FD&amp;C blue no. 2 aluminum lake and shellac. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, maize starch 5%, microcrystalline cellulose, magnesium stearate and poloxamer P407. In addition, the film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, titanium dioxide and talc. Gabapentin tablets, USP meets USP Dissolution Test 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>42385-980-11</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11) </PackageDescription>
    <NDC11Code>42385-0980-11</NDC11Code>
    <ProductNDC>42385-980</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240409</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217965</ApplicationNumber>
    <LabelerName>Laurus Labs Limited</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240409</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for.</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules, USP and gabapentin tablets, USP is gabapentin USP, which has the chemical name 1-(Aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin USP is a white to off-white crystalline solid. It is freely soluble in water and in alkaline and acidic solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.25. Each gabapentin capsule, USP contains 100 mg, 300 mg, or 400 mg of gabapentin USP and the following inactive ingredients: mannitol, pregelatinized starch and talc. The empty hard gelatin capsule shell consists of gelatin, sodium lauryl sulfate, and titanium dioxide. In addition 300 mg also contains iron oxide yellow and 400 mg also contains iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing FD&amp;C blue no. 2 aluminum lake and shellac. Each gabapentin tablet, USP contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients: copovidone, maize starch 5%, microcrystalline cellulose, magnesium stearate and poloxamer P407. In addition, the film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol-part hydrolyzed, titanium dioxide and talc. Gabapentin tablets, USP meets USP Dissolution Test 4.</Description>
  </NDC>
</NDCList>