RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>58118-0676-8</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0676-8) </PackageDescription>
    <NDC11Code>58118-0676-08</NDC11Code>
    <ProductNDC>58118-0676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203346</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale, LLC</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&amp;C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&amp;C Blue No. 2 lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0676-8</NDCCode>
    <PackageDescription>20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-8) </PackageDescription>
    <NDC11Code>71335-0676-08</NDC11Code>
    <ProductNDC>71335-0676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Morphine Sulfate</ProprietaryName>
    <NonProprietaryName>Morphine Sulfate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078761</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>MORPHINE SULFATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2024-04-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Morphine sulfate 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: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations[see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tabletsfor use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tabletsare not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
    <Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist.Each tablet contains the following inactive ingredients common to all strengths: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc and titanium dioxide.The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).The 15 mg tablets also contain: FD&amp;C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, macrogol/PEG 4000 and macrogol/PEG 400The 30 mg tablets also contain: D&amp;C Red # 27/Phloxine aluminum lake, FD&amp;C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400The 60 mg tablets also contain: FD&amp;C Yellow # 6 aluminum lake and macrogol/PEG 4000 and macrogol/PEG 400The 100 mg tablets also contain: FD&amp;C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, ferric oxide yellow, macrogol/PEG 4000 and macrogol/PEG 400The 200 mg tablets also contain: D&amp;C Yellow # 10 aluminum lake, FD&amp;C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400. Morphine sulfate, USP are white, feathery, silky crystals, cubical masses of crystals, or white crystalline powder, soluble in water, freely soluble in hot water, slightly soluble in alcohol but more so in hot alcohol, insoluble in chloroform and in ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
  </NDC>
  <NDC>
    <NDCCode>0078-0676-15</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-0676-15) </PackageDescription>
    <NDC11Code>00078-0676-15</NDC11Code>
    <ProductNDC>0078-0676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zofran</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171212</StartMarketingDate>
    <EndMarketingDate>20220531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020103</ApplicationNumber>
    <LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171212</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>16714-676-01</NDCCode>
    <PackageDescription>28 CAPSULE in 1 BOTTLE (16714-676-01) </PackageDescription>
    <NDC11Code>16714-0676-01</NDC11Code>
    <ProductNDC>16714-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sunitinib Malate</ProprietaryName>
    <NonProprietaryName>Sunitinib Malate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220218</StartMarketingDate>
    <EndMarketingDate>20260930</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213914</ApplicationNumber>
    <LabelerName>NorthStar RxLLC</LabelerName>
    <SubstanceName>SUNITINIB MALATE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220218</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260930</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sunitinib malate capsules are a kinase inhibitor indicated for: 1 treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. (1.1), 2 treatment of adult patients with advanced renal cell carcinoma (RCC). (1.2), 3 adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. (1.3), 4 treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. (1.4).</IndicationAndUsage>
    <Description>Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-[2-(Diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide, compound with (S)-2-hydroxybutanedioic acid. The molecular formula is C 22H 27FN 4O 2.C 4H 6O 5and the molecular weight is 532.57 Daltons. The chemical structure of sunitinib malate is. Sunitinib malate is light yellow to brownish orange colored powder with a pKa of 8.95. The solubility of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in the range of 12 to 70 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. Sunitinib malate capsules are supplied as printed hard shell capsules containing 12.5 mg, 25 mg, 37.5 mg or 50 mg of sunitinib (equivalent to 16.7 mg, 33.4 mg, 50.1 mg, or 66.8 mg of sunitinib malate, respectively) together with croscarmellose sodium, magnesium stearate, mannitol and povidone (K-30) as inactive ingredients. The reddish brown gelatin capsule shells contain ferric oxide red and titanium dioxide. The caramel gelatin capsule shells contain ferric oxide red, ferric oxide yellow, ferrosoferric oxide and titanium dioxide. The yellow gelatin capsule shells contain ferric oxide yellow and titanium dioxide. The white printing ink contains potassium hydroxide, shellac and titanium dioxide. The black printing ink contains ferrosoferric oxide, potassium hydroxide and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>45865-676-30</NDCCode>
    <PackageDescription>30 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-676-30) </PackageDescription>
    <NDC11Code>45865-0676-30</NDC11Code>
    <ProductNDC>45865-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160620</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205119</ApplicationNumber>
    <LabelerName>medsource pharmaceuticals</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C 16H 14F 2N 3NaO 4S x 1.5 H 2O, with a molecular weight of 432.4. The structural formula is:. Pantoprazole sodium, USP sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium, USP is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg). Each pantoprazole sodium delayed-release tablet, USP contains 45.1 mg or 22.56 mg of pantoprazole sodium, USP sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively). Pantoprazole sodium delayed-release tablets, USP contains the following inactive ingredients: ammonium hydroxide, crospovidone, hydroxyl propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, mannitol, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac, sodium carbonate, sodium hydroxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. Pantoprazole sodium delayed-release tablets, USP (40 mg and 20 mg) complies with USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>45963-676-11</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-676-11) </PackageDescription>
    <NDC11Code>45963-0676-11</NDC11Code>
    <ProductNDC>45963-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200203</StartMarketingDate>
    <EndMarketingDate>20270131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204161</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200203</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol succinate extended-release tablets are a beta-adrenergic blocker indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris. (1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3) .</IndicationAndUsage>
    <Description>Metoprolol succinate, USP is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.83, 47.66, 95.33 and 190.65 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether, and heptane. Inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose 2910, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyethylene glycol 400, polyethylene glycol 6000, polyethylene glycol 8000, talc and titanium dioxide. FDA approved dissolution test specifications differ from the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>45963-676-96</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45963-676-96) </PackageDescription>
    <NDC11Code>45963-0676-96</NDC11Code>
    <ProductNDC>45963-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metoprolol Succinate</ProprietaryName>
    <NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200203</StartMarketingDate>
    <EndMarketingDate>20270131</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204161</ApplicationNumber>
    <LabelerName>Actavis Pharma, Inc.</LabelerName>
    <SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200203</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metoprolol succinate extended-release tablets are a beta-adrenergic blocker indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris. (1.2) , 3 Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. (1.3) .</IndicationAndUsage>
    <Description>Metoprolol succinate, USP is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate, USP in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.83, 47.66, 95.33 and 190.65 mg of metoprolol succinate, USP equivalent to 25 mg, 50 mg, 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether, and heptane. Inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, crospovidone, ethylcellulose, hypromellose 2910, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polysorbate 80, polyethylene glycol 400, polyethylene glycol 6000, polyethylene glycol 8000, talc and titanium dioxide. FDA approved dissolution test specifications differ from the USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>47593-676-61</NDCCode>
    <PackageDescription>2000 mL in 1 BOTTLE, PLASTIC (47593-676-61) </PackageDescription>
    <NDC11Code>47593-0676-61</NDC11Code>
    <ProductNDC>47593-676</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ecolab Concentrated Foaming Antibacterial Handsoap</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251217</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Ecolab Inc.</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>8.9</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49349-676-12</NDCCode>
    <PackageDescription>8 TABLET in 1 BLISTER PACK (49349-676-12)</PackageDescription>
    <NDC11Code>49349-0676-12</NDC11Code>
    <ProductNDC>49349-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Epivir</ProprietaryName>
    <NonProprietaryName>Lamivudine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110913</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020564</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>LAMIVUDINE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-09</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>51407-676-60</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-676-60) </PackageDescription>
    <NDC11Code>51407-0676-60</NDC11Code>
    <ProductNDC>51407-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Posaconazole</ProprietaryName>
    <NonProprietaryName>Posaconazole</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220510</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212226</ApplicationNumber>
    <LabelerName>Golden State Medical Supply, Inc.</LabelerName>
    <SubstanceName>POSACONAZOLE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220912</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Posaconazole delayed-release tablets are an azole antifungal indicated as follows: 1 Posaconazole delayed-release tabletsare indicated for the prophylaxis of invasive Aspergillusand Candidainfections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: ( 1.2) Posaconazole delayed-release tablets:adults and pediatric patients 13 years of age and older .</IndicationAndUsage>
    <Description>Posaconazole delayed-release tablets are an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3 R,5 R)-5- (2,4-difluorophenyl)tetrahydro-5- (1 H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1 S,2 S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3 H-1,2,4-triazol-3-one with an empirical formula of C 37H 42F 2N 8O 4and a molecular weight of 700.8. The chemical structure is:. Posaconazole is a white powder with a low aqueous solubility. Posaconazole delayed-release tablets are yellow, modified, oval, convex tablets containing 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: Hypromellose Acetate Succinate, Microcrystalline Cellulose, Hydroxypropyl Cellulose, Croscarmellose Sodium, Silicon Dioxide, and Magnesium Stearate. The color coating contains (Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, Ferric Oxide Yellow, and Ferrosoferric Oxide).</Description>
  </NDC>
  <NDC>
    <NDCCode>51523-676-20</NDCCode>
    <PackageDescription>1 CONTAINER in 1 CARTON (51523-676-20)  &gt; 20 g in 1 CONTAINER</PackageDescription>
    <NDC11Code>51523-0676-20</NDC11Code>
    <ProductNDC>51523-676</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Face It Aura Color Control</ProprietaryName>
    <ProprietaryNameSuffix>32800676</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate, Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>THEFACESHOP CO., LTD.</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>.8; 2.3; .2</StrengthNumber>
    <StrengthUnit>g/20g; g/20g; g/20g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>52311-676-01</NDCCode>
    <PackageDescription>1 TUBE in 1 BOX (52311-676-01)  / 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>52311-0676-01</NDC11Code>
    <ProductNDC>52311-676</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nena Mineral Sunscreen Spf 30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide,titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Ironwood Clay Company, Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2.3; 22</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-02-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. : 1 Absorbs throughout the UVA/UVB spectrum to provide sunburn protection., 2 Broad spectrum., 3 Filters/Screens UVA/UVB rays., 4 Helps prevent sunburn., 5 Helps protect from sunburn., 6 If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun., 7 Sun Protection Factor 30 / SPF 30., 8 Sunscreen.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58657-676-01</NDCCode>
    <PackageDescription>100 TABLET, COATED in 1 BOTTLE (58657-676-01) </PackageDescription>
    <NDC11Code>58657-0676-01</NDC11Code>
    <ProductNDC>58657-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208921</ApplicationNumber>
    <LabelerName>Method Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated.  Skin and Skin Structure Infections ( 1.1).  Bone and Joint Infections ( 1.2).  Complicated Intra-Abdominal Infections ( 1.3).  Infectious Diarrhea ( 1.4).  Typhoid Fever (Enteric Fever) ( 1.5).  Uncomplicated Cervical and Urethral Gonorrhea ( 1.6).  Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7).  Plague in adult and pediatric patients ( 1.8).  Chronic Bacterial Prostatitis ( 1.9).  Lower Respiratory Tract Infections ( 1.10).     Acute Exacerbation of Chronic Bronchitis.  Urinary Tract Infections ( 1.11).     Urinary Tract Infections (UTI).     Acute Uncomplicated Cystitis.     Complicated UTI and Pyelonephritis in Pediatric Patients.  Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</IndicationAndUsage>
    <Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
  </NDC>
  <NDC>
    <NDCCode>58657-676-50</NDCCode>
    <PackageDescription>500 TABLET, COATED in 1 BOTTLE (58657-676-50) </PackageDescription>
    <NDC11Code>58657-0676-50</NDC11Code>
    <ProductNDC>58657-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200812</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208921</ApplicationNumber>
    <LabelerName>Method Pharmaceuticals, LLC</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200812</StartMarketingDatePackage>
    <EndMarketingDatePackage>20231231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated.  Skin and Skin Structure Infections ( 1.1).  Bone and Joint Infections ( 1.2).  Complicated Intra-Abdominal Infections ( 1.3).  Infectious Diarrhea ( 1.4).  Typhoid Fever (Enteric Fever) ( 1.5).  Uncomplicated Cervical and Urethral Gonorrhea ( 1.6).  Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7).  Plague in adult and pediatric patients ( 1.8).  Chronic Bacterial Prostatitis ( 1.9).  Lower Respiratory Tract Infections ( 1.10).     Acute Exacerbation of Chronic Bronchitis.  Urinary Tract Infections ( 1.11).     Urinary Tract Infections (UTI).     Acute Uncomplicated Cystitis.     Complicated UTI and Pyelonephritis in Pediatric Patients.  Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (    1.13).</IndicationAndUsage>
    <Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-676-10</NDCCode>
    <PackageDescription>10 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-676-10) </PackageDescription>
    <NDC11Code>60760-0676-10</NDC11Code>
    <ProductNDC>60760-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210521</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208921</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210528</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated.  Skin and Skin Structure Infections ( 1.1).  Bone and Joint Infections ( 1.2).  Complicated Intra-Abdominal Infections ( 1.3).  Infectious Diarrhea ( 1.4).  Typhoid Fever (Enteric Fever) ( 1.5).  Uncomplicated Cervical and Urethral Gonorrhea ( 1.6).  Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7).  Plague in adult and pediatric patients ( 1.8).  Chronic Bacterial Prostatitis ( 1.9).  Lower Respiratory Tract Infections ( 1.10).     Acute Exacerbation of Chronic Bronchitis.  Urinary Tract Infections ( 1.11).     Urinary Tract Infections (UTI).     Acute Uncomplicated Cystitis.     Complicated UTI and Pyelonephritis in Pediatric Patients.  Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</IndicationAndUsage>
    <Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
  </NDC>
  <NDC>
    <NDCCode>60760-676-20</NDCCode>
    <PackageDescription>20 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-676-20) </PackageDescription>
    <NDC11Code>60760-0676-20</NDC11Code>
    <ProductNDC>60760-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciprofloxacin</ProprietaryName>
    <NonProprietaryName>Ciprofloxacin</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210521</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208921</ApplicationNumber>
    <LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
    <SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210521</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated.  Skin and Skin Structure Infections ( 1.1).  Bone and Joint Infections ( 1.2).  Complicated Intra-Abdominal Infections ( 1.3).  Infectious Diarrhea ( 1.4).  Typhoid Fever (Enteric Fever) ( 1.5).  Uncomplicated Cervical and Urethral Gonorrhea ( 1.6).  Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7).  Plague in adult and pediatric patients ( 1.8).  Chronic Bacterial Prostatitis ( 1.9).  Lower Respiratory Tract Infections ( 1.10).     Acute Exacerbation of Chronic Bronchitis.  Urinary Tract Infections ( 1.11).     Urinary Tract Infections (UTI).     Acute Uncomplicated Cystitis.     Complicated UTI and Pyelonephritis in Pediatric Patients.  Acute Sinusitis ( 1.12). Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13).</IndicationAndUsage>
    <Description>Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl- 6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)- 3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17H 18FN 3O 3and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 250 mg and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-676-71</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (61919-676-71) </PackageDescription>
    <NDC11Code>61919-0676-71</NDC11Code>
    <ProductNDC>61919-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lovastatin</ProprietaryName>
    <NonProprietaryName>Lovastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160303</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075636</ApplicationNumber>
    <LabelerName>DIRECT RX</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>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160303</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lovastatin tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, lovastatin tablets USP are indicated to reduce the risk of. - Myocardial infarction. - Unstable angina. - Coronary revascularization procedures. (See CLINICAL PHARMACOLOGY, Clinical Studies). Coronary Heart Disease. Lovastatin tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. ____________________________________________________. 2Classification of Hyperlipoproteinemias. Lipid Elevations. Type. Lipoproteins Elevated. Major. Minor. I. chylomicrons. TG. ↑→C. IIa. LDL. C. −. IIb. LDL, VLDL. C. TG. III (rare). IDL. C/TG. −. IV. VLDL. TG. ↑→C. V (rare). chylomicrons, VLDL. TG. ↑→C. IDL = intermediate-density lipoprotein. Adolescent Patients with Heterozygous Familial Hypercholesterolemia. Lovastatin tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present. 1. LDL-C remains &gt;189 mg/dL or. 2. LDL-C remains &gt;160 mg/dL and. there is a positive family history of premature cardiovascular disease or.  two or more other CVD risk factors are present in the adolescent patients General Recommendations. Prior to initiating therapy with lovastatin tablets USP, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL (&lt;4.5 mmol/L), LDL-C can be estimated using the following equation. LDL-C = total-C - [0.2 x (TG) + HDL-C]. For TG levels &gt;400 mg/dL (&gt;4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, lovastatin tablets USP are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below. CHD, coronary heart disease Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of &lt;100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcategory. Almost all people with 0-1 risk factor have a 10-year risk &lt;10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary. NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories. Risk Category. LDL Goal (mg/dL). LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL). LDL Level at Which to Consider Drug Therapy (mg/dL). CHD*or CHD risk equivalents (10-year risk &gt;20%). &lt;100. ≥100. ≥130 (100-129: drug optional)†. 2+ Risk factors (10-year risk ≤20%). &lt;130. ≥130. 10-year risk 10-20%: ≥130 10-year risk &lt;10%: ≥160. 0-1 Risk factor. &lt;160. ≥160. ≥190 (160-189: LDL-lowering drug optional). After the LDL-C goal has been achieved, if the TG is still &gt;200 mg/dL, non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category. At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C is &gt;130 mg/dL (see NCEP Guidelines above). Since the goal of treatment is to lower LDL-C, the NCEP recommends that LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the total-C be used to monitor therapy. Although lovastatin tablets USP may be useful to reduce elevated LDL-C levels in patients with combined hypercholesterolemia and hypertriglyceridemia where hypercholesterolemia is the major abnormality (Type IIb hyperlipoproteinemia), it has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL or IDL (i.e., hyperlipoproteinemia types I, III, IV, or V).2. 2 Classification of Hyperlipoproteinemias. The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below. Category. Total-C (mg/dL). LDL-C (mg/dL). Acceptable. &lt;170. &lt;110. Borderline. 170 to 199. 110 to 129. High. ≥200. ≥130.</IndicationAndUsage>
    <Description>Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding ß-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin is [1S-[1 α(R*),3 α,7ß,8ß(2S*,4S*), 8aß]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovastatin is C24H3605 and its molecular weight is 404.55. Its structural formula is. [Chemical Structure]. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. In addition the 10 mg tablets also contain red iron oxide and yellow iron oxide; the 20 mg tablets also contain FD&amp;C blue No. 2; and the 40 mg tablets also contain D&amp;C yellow No. 10 and FD&amp;C blue No. 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64980-676-09</NDCCode>
    <PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-676-09) </PackageDescription>
    <NDC11Code>64980-0676-09</NDC11Code>
    <ProductNDC>64980-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pantoprazole Sodium</ProprietaryName>
    <NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250312</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219087</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250312</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pantoprazole sodium delayed-release tablets are indicated for.</IndicationAndUsage>
    <Description>The active ingredient in pantoprazole sodium, USP, a PPI, is a substituted 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridyl)methyl]sulfinyl]benzimidazole, sodium salt, sesquihydrate, a compound that inhibits gastric acid secretion. Its molecular formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.37. The structural formula is. Pantoprazole sodium, USP is a white to off white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, methanol and dehydrated alcohol, practically insoluble in hexane and dichloromethane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths 20 mg pantoprazole (equivalent to 22.55 mg of pantoprazole sodium) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium). Pantoprazole sodium delayed-release tablet, USP contains the following inactive ingredients: calcium stearate, crospovidone, ferric oxide yellow, hydroxy propyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer dispersion, sodium carbonate and triethyl citrate. Additionally, each tablet is printed with black pharmaceutical ink which contains ferrosoferric oxide, propylene glycol and shellac. It complies with USP dissolution test 3.</Description>
  </NDC>
  <NDC>
    <NDCCode>65162-676-84</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (65162-676-84)  / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>65162-0676-84</NDC11Code>
    <ProductNDC>65162-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azelastine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Azelastine</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20170905</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204660</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
    <SubstanceName>AZELASTINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170905</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azelastine hydrochloride (HCl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.</IndicationAndUsage>
    <Description>Azelastine HCl nasal spray, 0.1%, 137 micrograms (mcg), is an antihistamine formulated as a metered-spray solution for intranasal administration. Azelastine HCl, USP occurs as a white, almost odorless, crystalline powder with a bitter taste. It has a molecular weight of 418.37. It is sparingly soluble in water, methanol, and propylene glycol and slightly soluble in ethanol, octanol, and glycerine. It has a melting point of about 225°C and the pH of a saturated solution is between 5.0 and 5.4. Its chemical name is (±)-1-(2H)-phthalazinone,4-[(4-chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-, monohydrochloride. Its molecular formula is C22H24ClN3OHCl with the following chemical structure. Azelastine HCl nasal spray, 0.1% contains 0.1% azelastine HCl, USP in an aqueous solution at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL), citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride. After priming [see Dosage and Administration (2.3)], each metered spray delivers a 0.137 mL mean volume containing 137 mcg of azelastine HCl, USP (equivalent to 125 mcg of azelastine base). The bottle can deliver 200 metered sprays.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-676-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (65862-676-01) </PackageDescription>
    <NDC11Code>65862-0676-01</NDC11Code>
    <ProductNDC>65862-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203346</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is:. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&amp;C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&amp;C Blue No. 2 lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-676-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (65862-676-05) </PackageDescription>
    <NDC11Code>65862-0676-05</NDC11Code>
    <ProductNDC>65862-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203346</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is:. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&amp;C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&amp;C Blue No. 2 lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-676-99</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (65862-676-99) </PackageDescription>
    <NDC11Code>65862-0676-99</NDC11Code>
    <ProductNDC>65862-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alprazolam</ProprietaryName>
    <NonProprietaryName>Alprazolam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203346</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>ALPRAZOLAM</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150731</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Alprazolam tablets are indicated for the: : 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
    <Description>Alprazolam tablets, USP contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is:. Alprazolam USP is a white to off-white, crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each alprazolam tablet USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam USP. Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&amp;C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&amp;C Blue No. 2 lake.</Description>
  </NDC>
  <NDC>
    <NDCCode>67046-676-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-676-30) </PackageDescription>
    <NDC11Code>67046-0676-30</NDC11Code>
    <ProductNDC>67046-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>Contract Pharmacy Services-PA</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>40</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>20170918</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of  HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1 S-[1α,3α,7β,8β(2 S*,4 S*),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5 and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole , ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>71205-676-08</NDCCode>
    <PackageDescription>8 CAPSULE in 1 BOTTLE (71205-676-08) </PackageDescription>
    <NDC11Code>71205-0676-08</NDC11Code>
    <ProductNDC>71205-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ergocalciferol Capsules,</ProprietaryName>
    <NonProprietaryName>Ergocalciferol Capsules,</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181210</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204276</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>ERGOCALCIFEROL</SubstanceName>
    <StrengthNumber>1.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240927</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ergocalciferol Capsules are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
    <Description>Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU. Each capsule contains 1.25 mg (50,000 International Units vitamin D) of ergocalciferol, USP, in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9, 10-secoergosta-5, 7, 10(19), 22-tetraen-3-ol, (3ß, 5Z, 7E, 22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula. Inactive Ingredients: Butylated hydroxytoluene, D&amp;C Yellow #10, FD&amp;C Blue #1, Gelatin, Glycerin, Propylene Glycol, Shellac, Simethicone, Soybean oil and Titanium Dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-676-30</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-676-30) </PackageDescription>
    <NDC11Code>72189-0676-30</NDC11Code>
    <ProductNDC>72189-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hcl Er(sr)</ProprietaryName>
    <NonProprietaryName>Bupropion Hcl Er(sr)</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216800</ApplicationNumber>
    <LabelerName>DriectRx</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is. [bupropionhclstructure]. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&amp;C Red #40, the 150 mg tablet contains FD&amp;C Blue #1 and D&amp;C Yellow #10 Lake and the 200 mg tablet contains D&amp;C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-676-60</NDCCode>
    <PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-676-60) </PackageDescription>
    <NDC11Code>72189-0676-60</NDC11Code>
    <ProductNDC>72189-676</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bupropion Hcl Er(sr)</ProprietaryName>
    <NonProprietaryName>Bupropion Hcl Er(sr)</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260430</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216800</ApplicationNumber>
    <LabelerName>DriectRx</LabelerName>
    <SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260430</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Bupropion hydrochloride, USP is an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.20. The molecular formula is C 13H 18ClNOHCl. Bupropion hydrochloride is white powder, and soluble in water, 0.1 N Hydrochloric acid and in alcohol. The structural formula is. [bupropionhclstructure]. Bupropion hydrochloride extended-release tablets USP (SR) are supplied for oral administration as 100 mg (red), 150 mg (green), and 200 mg (yellow), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride USP and the inactive ingredients: colloidal silicon dioxide, diluted hydrochloride acid, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&amp;C Red #40, the 150 mg tablet contains FD&amp;C Blue #1 and D&amp;C Yellow #10 Lake and the 200 mg tablet contains D&amp;C Yellow #10 Lake. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>58118-0001-8</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0001-8)</PackageDescription>
    <NDC11Code>58118-0001-08</NDC11Code>
    <ProductNDC>58118-0001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methylprednisolone</ProprietaryName>
    <NonProprietaryName>Methylprednisolone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19971031</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040189</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale</LabelerName>
    <SubstanceName>METHYLPREDNISOLONE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58118-0003-8</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0003-8)</PackageDescription>
    <NDC11Code>58118-0003-08</NDC11Code>
    <ProductNDC>58118-0003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ethambutol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ethambutol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090704</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078939</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale, LLC</LabelerName>
    <SubstanceName>ETHAMBUTOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58118-0004-8</NDCCode>
    <PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0004-8)</PackageDescription>
    <NDC11Code>58118-0004-08</NDC11Code>
    <ProductNDC>58118-0004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyrazinamide</ProprietaryName>
    <NonProprietaryName>Pyrazinamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19710603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA080157</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale, LLC</LabelerName>
    <SubstanceName>PYRAZINAMIDE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Antimycobacterial [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-06-21</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>58118-0005-8</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0005-8)</PackageDescription>
    <NDC11Code>58118-0005-08</NDC11Code>
    <ProductNDC>58118-0005</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>Clinical Solutions Wholesale</LabelerName>
    <SubstanceName>SIMVASTATIN</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>2018-11-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
</NDCList>