RESTful Lookup — Test-Drive (2007 – 2026)

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    <NDCCode>62332-244-90</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-244-90) </PackageDescription>
    <NDC11Code>62332-0244-90</NDC11Code>
    <ProductNDC>62332-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208705</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-244-30</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-244-30) </PackageDescription>
    <NDC11Code>62332-0244-30</NDC11Code>
    <ProductNDC>62332-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208705</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
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  <NDC>
    <NDCCode>62332-244-91</NDCCode>
    <PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-244-91) </PackageDescription>
    <NDC11Code>62332-0244-91</NDC11Code>
    <ProductNDC>62332-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208705</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-10-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>16590-244-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-244-90)</PackageDescription>
    <NDC11Code>16590-0244-90</NDC11Code>
    <ProductNDC>16590-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ryzolt</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081230</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021745</ApplicationNumber>
    <LabelerName>Stat Rx USA</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-10</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>RYZOLT 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>C16H25NO2 ·HCl. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder that is freely soluble in water and ethanol. RYZOLT extended-release tablets are for oral administration and contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride. The tablets are white to off-white in color. The inactive ingredients in the tablet are colloidal silicon dioxide, pregelatinized modified starch, hydrogenated vegetable oil, magnesium stearate, polyvinyl acetate, povidone, sodium lauryl sulfate and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>24979-244-07</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (24979-244-07) </PackageDescription>
    <NDC11Code>24979-0244-07</NDC11Code>
    <ProductNDC>24979-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tenormin</ProprietaryName>
    <NonProprietaryName>Atenolol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240801</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018240</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>ATENOLOL</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypertension. TENORMIN is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. TENORMIN may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis. TENORMIN is indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction. TENORMIN is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient’s clinical condition allows. (See DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS.) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.</IndicationAndUsage>
    <Description>TENORMIN® (atenolol), a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2'-hydroxy-3'-[(1- methylethyl) amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). TENORMIN is available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.</Description>
  </NDC>
  <NDC>
    <NDCCode>33342-244-10</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (33342-244-10) </PackageDescription>
    <NDC11Code>33342-0244-10</NDC11Code>
    <ProductNDC>33342-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil Amlodipine And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250718</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207088</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>OLMESARTAN MEDOXOMIL; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>40; 5; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250718</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
    <Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets USP, provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25CIN2O5C6H6O3S. The hydrochlorothiazide USP component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1 dioxide. Its empirical formula is C7H8CIN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contains olmesartan medoxomil USP, a white to light yellowish-white powder or crystalline powder, amlodipine besylate USP, a white to off-white crystalline powder, and hydrochlorothiazide USP, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>45865-244-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (45865-244-90) </PackageDescription>
    <NDC11Code>45865-0244-90</NDC11Code>
    <ProductNDC>45865-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080926</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078643</ApplicationNumber>
    <LabelerName>Medsource Pharmaceuticals</LabelerName>
    <SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
    <Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the molecular formula C 20H 21N  HCl and a molecular weight of 311.9. It has a melting point of 217ºC, and a pK aof 8.47 at 25ºC. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride is designated chemically as 3-( 5H-dibenzo[ a, d] cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride is supplied as 5 mg or 10 mg tablets for oral administration. Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch (maize) and titanium dioxide. In addition 5 mg also contains D&amp;C yellow #10 aluminum lake and FD&amp;C yellow #6 aluminum lake and 10 mg also contains yellow iron oxide. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>46708-244-90</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-90) </PackageDescription>
    <NDC11Code>46708-0244-90</NDC11Code>
    <ProductNDC>46708-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibric Acid</ProprietaryName>
    <NonProprietaryName>Fenofibric Acid</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170515</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208705</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
    <SubstanceName>FENOFIBRIC ACID</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. ·         Reduce TG in patients with severe hypertriglyceridemia (1.1). ·         Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDLC in patients with primary hypercholesterolemia or mixed dyslipidemia (1.2). Limitations of Use: Fenofibrate at a dose equivalent to 135 mg of fenofibric acid delayed-release capsules did not reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus (5.1).</IndicationAndUsage>
    <Description>Fenofibric acid delayed-release capsules are a 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 empirical formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water and methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder, which is stable under ordinary conditions. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, povidone, water, hydroxylpropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, iron oxide yellow, and iron oxide red. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, iron oxide yellow, and FD&amp;C Blue #2. The capsule shells are printed with edible white ink and black ink. The edible white ink contains shellac, propylene glycol, potassium hydroxide, and titanium dioxide and the edible black ink contains shellac, propylene glycol, iron oxide black and, potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>55700-244-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (55700-244-90) </PackageDescription>
    <NDC11Code>55700-0244-90</NDC11Code>
    <ProductNDC>55700-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lovastatin</ProprietaryName>
    <NonProprietaryName>Lovastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20071101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078296</ApplicationNumber>
    <LabelerName>Lake Erie Medical DBA Quality Care Products LLC</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>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>68382-244-16</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68382-244-16) </PackageDescription>
    <NDC11Code>68382-0244-16</NDC11Code>
    <ProductNDC>68382-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Imatinib Mesylate</ProprietaryName>
    <NonProprietaryName>Imatinib Mesylate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210658</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>IMATINIB MESYLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRαfusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRαfusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9), 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
    <Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets contain imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate and its structural formula is. Imatinib mesylate is a pale yellow to light green powder. Its molecular formula is. C29H31N7OCH4SO3 and its molecular weight is 589.7. It is freely soluble in water and sparingly soluble in methanol. Each film-coated imatinib mesylate tablet contains 100 mg or 400 mg of imatinib free base and contains following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone (Type A), hypromellose, magnesium stearate, mannitol and microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide and yellow iron oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70934-244-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-244-90) </PackageDescription>
    <NDC11Code>70934-0244-90</NDC11Code>
    <ProductNDC>70934-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
    <NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190122</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208898</ApplicationNumber>
    <LabelerName>Denton Pharma, Inc. DBA Northwind Pharmaceuticals</LabelerName>
    <SubstanceName>ROSUVASTATIN CALCIUM</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>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71205-244-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71205-244-90) </PackageDescription>
    <NDC11Code>71205-0244-90</NDC11Code>
    <ProductNDC>71205-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
    <NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076820</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-10-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Benazepril HCl tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with thiazide diuretics.</IndicationAndUsage>
    <Description>Benazepril HCl, USP is a white to off-white crystalline powder, soluble (&gt; 100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is benazepril 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C24H28N2O5HCl and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril HCl tablets, USP are supplied as white, round, biconvex tablets containing either 5 mg, 10 mg, 20 mg, or 40 mg of benazepril HCl, USP for oral administration. The inactive ingredients are  crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-244-60</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (71610-244-60) </PackageDescription>
    <NDC11Code>71610-0244-60</NDC11Code>
    <ProductNDC>71610-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sucralfate</ProprietaryName>
    <NonProprietaryName>Sucralfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19961111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070848</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>SUCRALFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Aluminum Complex [EPC],Organometallic Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sucralfate tablets, USP are indicated in: 1 Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.</IndicationAndUsage>
    <Description>Sucralfate, USP is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis(hydrogen sulfate), aluminum complex. R = SO3Al(OH)2. Tablets for oral administration contain 1 g of sucralfate, USP and the following inactive ingredients: corn starch, magnesium stearate, and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>72865-244-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (72865-244-90) </PackageDescription>
    <NDC11Code>72865-0244-90</NDC11Code>
    <ProductNDC>72865-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levothyroxine Sodium</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230118</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA215259</ApplicationNumber>
    <LabelerName>XLCare Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>.15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-02-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: : 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium tablets may induce hyperthyroidism [see Warnings and Precautions (5.4)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
    <Description>Levothyroxine sodium tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is identical in chemical structure to the T4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4 xH2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine sodium tablets for oral administration are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxyanisole, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate and color additive(s). Table 6 provides a listing of the color additives by tablet strength. FDA approved Dissolution test differs from the USP dissolution test. FDA approved Assay test differs from the USP assay test.</Description>
  </NDC>
  <NDC>
    <NDCCode>76420-244-90</NDCCode>
    <PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-244-90) </PackageDescription>
    <NDC11Code>76420-0244-90</NDC11Code>
    <ProductNDC>76420-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201384</ApplicationNumber>
    <LabelerName>Asclemed USA, Inc.</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2022-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use.</IndicationAndUsage>
    <Description>Tramadol hydrochloride is an opioid agonist in an extended-release tablet formulation for oral use. The chemical name is (±) cis-2-[(dimethylamino) methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:. The molecular weight of tramadol hydrochloride is 299.84. It is a white, crystalline powder that is freely soluble in water and methanol, very slightly soluble in acetone 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 tablets contain 100 mg, 200 mg or 300 mg of tramadol hydrochloride, USP in an extended-release formulation. The tablets are white in color and contain the inactive ingredients pregelatinized maize starch, hypromellose, mannitol, magnesium stearate, cellulose acetate and polyethylene glycol. Imprinting ink contains, shellac glaze, iron oxide black, N-butyl alcohol, ammonium hydroxide and propylene glycol.</Description>
  </NDC>
  <NDC>
    <NDCCode>82804-244-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (82804-244-90) </PackageDescription>
    <NDC11Code>82804-0244-90</NDC11Code>
    <ProductNDC>82804-244</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Digoxin</ProprietaryName>
    <NonProprietaryName>Digoxin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220901</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076268</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>DIGOXIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: 1  Treatment of mild to moderate heart failure in adults. ( 1.1) , 2  Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2) , 3  Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3) .</IndicationAndUsage>
    <Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl‑ (1→4)- O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo‑ hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41H 64O 14, its molecular weight is 780.95, and its structural formula is. Digoxin exists as odorless white crystals that melt with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients. 0.250 mg - colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid. 0.125 mg - colloidal silicon dioxide, croscarmellose sodium, D&amp;C yellow aluminum lake #10, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-001-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-001-90) </PackageDescription>
    <NDC11Code>62332-0001-90</NDC11Code>
    <ProductNDC>62332-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078916</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-002-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-002-90) </PackageDescription>
    <NDC11Code>62332-0002-90</NDC11Code>
    <ProductNDC>62332-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078916</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-11-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160129</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>62332-003-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-003-90) </PackageDescription>
    <NDC11Code>62332-0003-90</NDC11Code>
    <ProductNDC>62332-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078894</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-004-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-004-90) </PackageDescription>
    <NDC11Code>62332-0004-90</NDC11Code>
    <ProductNDC>62332-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078894</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-005-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-005-90) </PackageDescription>
    <NDC11Code>62332-0005-90</NDC11Code>
    <ProductNDC>62332-005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078894</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-006-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-006-90) </PackageDescription>
    <NDC11Code>62332-0006-90</NDC11Code>
    <ProductNDC>62332-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078894</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-007-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-007-90) </PackageDescription>
    <NDC11Code>62332-0007-90</NDC11Code>
    <ProductNDC>62332-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078894</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-027-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62332-027-90) </PackageDescription>
    <NDC11Code>62332-0027-90</NDC11Code>
    <ProductNDC>62332-027</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090428</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for. ·         Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). ·         Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2). ·         Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium USP is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium tablets USP are available for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: D&amp;C yellow No. 10 aluminum lake, FD&amp;C blue No.2 aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-028-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62332-028-90) </PackageDescription>
    <NDC11Code>62332-0028-90</NDC11Code>
    <ProductNDC>62332-028</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090428</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for. ·         Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). ·         Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2). ·         Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium USP is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium tablets USP are available for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: D&amp;C yellow No. 10 aluminum lake, FD&amp;C blue No.2 aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-029-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62332-029-90) </PackageDescription>
    <NDC11Code>62332-0029-90</NDC11Code>
    <ProductNDC>62332-029</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160523</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090428</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160523</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for. ·         Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). ·         Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2). ·         Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3).</IndicationAndUsage>
    <Description>Losartan potassium USP is an angiotensin II receptor blocker acting on the AT1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its empirical formula is C22H22ClKN6O, and its structural formula is. Losartan potassium tablets USP are available for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: D&amp;C yellow No. 10 aluminum lake, FD&amp;C blue No.2 aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-041-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-041-90) </PackageDescription>
    <NDC11Code>62332-0041-90</NDC11Code>
    <ProductNDC>62332-041</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irbesartan</ProprietaryName>
    <NonProprietaryName>Irbesartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091236</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>IRBESARTAN</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for:    Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2).</IndicationAndUsage>
    <Description>Irbesartan tablet is an angiotensin II receptor (AT1  subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a  2-butyl-3-[p-(o-1H-tetrazol-5­ ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and the structural  formula. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg and 300 mg of irbesartan. Inactive ingredients include: croscarmellose sodium, lactose, magnesium stearate and povidone k-30.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-042-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-042-90) </PackageDescription>
    <NDC11Code>62332-0042-90</NDC11Code>
    <ProductNDC>62332-042</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irbesartan</ProprietaryName>
    <NonProprietaryName>Irbesartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091236</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>IRBESARTAN</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for:    Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2).</IndicationAndUsage>
    <Description>Irbesartan tablet is an angiotensin II receptor (AT1  subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a  2-butyl-3-[p-(o-1H-tetrazol-5­ ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and the structural  formula. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg and 300 mg of irbesartan. Inactive ingredients include: croscarmellose sodium, lactose, magnesium stearate and povidone k-30.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-043-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-043-90) </PackageDescription>
    <NDC11Code>62332-0043-90</NDC11Code>
    <ProductNDC>62332-043</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Irbesartan</ProprietaryName>
    <NonProprietaryName>Irbesartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160701</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091236</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>IRBESARTAN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Irbesartan tablet is an angiotensin II receptor blocker (ARB) indicated for:    Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1). Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. (1.2).</IndicationAndUsage>
    <Description>Irbesartan tablet is an angiotensin II receptor (AT1  subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a  2-butyl-3-[p-(o-1H-tetrazol-5­ ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C25H28N6O, and the structural  formula. Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan tablets, USP are available for oral administration in unscored tablets containing 75 mg, 150 mg and 300 mg of irbesartan. Inactive ingredients include: croscarmellose sodium, lactose, magnesium stearate and povidone k-30.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-044-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-044-90) </PackageDescription>
    <NDC11Code>62332-0044-90</NDC11Code>
    <ProductNDC>62332-044</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan</ProprietaryName>
    <NonProprietaryName>Valsartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091367</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>VALSARTAN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2021-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160520</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype. Valsartan is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Valsartan is available as tablets for oral administration, containing 40 mg, 80 mg, 160 mg or 320 mg of valsartan. The inactive ingredients of the tablets are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinised starch, poloxamer 188, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol. Additionally Valsartan 40 mg contains Iron Oxide Yellow, Valsartan 80 mg contains Iron Oxide Red, Valsartan 160 mg contains Iron Oxide Yellow, Iron Oxide Red and Valsartan 320 mg contains Iron Oxide Yellow, Iron Oxide Black, Iron Oxide Red.</Description>
  </NDC>
</NDCList>