RESTful Lookup — Test-Drive (2007 – 2026)

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  <NDC>
    <NDCCode>47781-571-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-571-73)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0571-73</NDC11Code>
    <ProductNDC>47781-571</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180228</StartMarketingDate>
    <EndMarketingDate>20221101</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180228</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>47781-571-72</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-571-72)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0571-72</NDC11Code>
    <ProductNDC>47781-571</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180228</StartMarketingDate>
    <EndMarketingDate>20221101</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-11-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180228</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>83703-571-73</NDCCode>
    <PackageDescription>273 VIAL, SINGLE-DOSE in 1 CARTON (83703-571-73)  / 3 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>83703-0571-73</NDC11Code>
    <ProductNDC>83703-571</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Enfortumab Vedotin</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <StartMarketingDate>20191218</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Bamboo US Bidco LCC</LabelerName>
    <SubstanceName>ENFORTUMAB VEDOTIN</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-17</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-DEC-19</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>47781-530-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-530-73)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0530-73</NDC11Code>
    <ProductNDC>47781-530</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciclopirox</ProprietaryName>
    <NonProprietaryName>Ciclopirox</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170214</StartMarketingDate>
    <EndMarketingDate>20210901</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020519</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>CICLOPIROX</SubstanceName>
    <StrengthNumber>7.7</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170214</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>47781-532-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-532-73)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0532-73</NDC11Code>
    <ProductNDC>47781-532</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide Cream (emulsified Base)</ProprietaryName>
    <NonProprietaryName>Fluocinonide Cream (emulsified Base)</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170714</StartMarketingDate>
    <EndMarketingDate>20210601</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016908</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170714</StartMarketingDatePackage>
    <EndMarketingDatePackage>20210601</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>47781-533-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-533-73)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0533-73</NDC11Code>
    <ProductNDC>47781-533</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide Gel</ProprietaryName>
    <NonProprietaryName>Fluocinonide Gel</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170214</StartMarketingDate>
    <EndMarketingDate>20240501</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017373</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170214</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240401</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinonide Gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinonide Gel, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Gel contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust the pH), and water (purified). This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-543-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-543-73)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0543-73</NDC11Code>
    <ProductNDC>47781-543</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Econazole Nitrate Cream</ProprietaryName>
    <NonProprietaryName>Econazole Nitrate Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170907</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018751</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>ECONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC],Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170907</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>47781-569-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-569-73)  / 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0569-73</NDC11Code>
    <ProductNDC>47781-569</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluocinonide</ProprietaryName>
    <NonProprietaryName>Fluocinonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171002</StartMarketingDate>
    <EndMarketingDate>20241101</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA016909</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>FLUOCINONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20171002</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240701</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>Fluocinonide Ointment, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Ointment contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, white petrolatum, propylene carbonate, propylene glycol and white wax. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-570-73</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (47781-570-73)  &gt; 30 g in 1 TUBE</PackageDescription>
    <NDC11Code>47781-0570-73</NDC11Code>
    <ProductNDC>47781-570</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine</ProprietaryName>
    <NonProprietaryName>Lidocaine</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180112</StartMarketingDate>
    <EndMarketingDate>20220901</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>LIDOCAINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-09-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20180219</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63187-571-30</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63187-571-30) </PackageDescription>
    <NDC11Code>63187-0571-30</NDC11Code>
    <ProductNDC>63187-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130321</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202519</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets, USP 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 hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. 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 have also 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 (e.g., 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. Add-On TherapyValsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.Replacement TherapyValsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components.Initial TherapyValsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rise to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white, fine hygroscopic powder. It is soluble in ethanol and methanol and practically insoluble in water.Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc, and titanium dioxide. In addition, the 80 mg/12.5 mg and 160 mg/12.5 mg contains iron oxide red and iron oxide yellow, the 160 mg/25 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 320 mg/12.5 mg contains iron oxide black and iron oxide red, and the 320 mg/25 mg contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-571-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (63187-571-60) </PackageDescription>
    <NDC11Code>63187-0571-60</NDC11Code>
    <ProductNDC>63187-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130321</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202519</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets, USP 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 hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. 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 have also 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 (e.g., 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. Add-On TherapyValsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.Replacement TherapyValsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components.Initial TherapyValsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rise to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white, fine hygroscopic powder. It is soluble in ethanol and methanol and practically insoluble in water.Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc, and titanium dioxide. In addition, the 80 mg/12.5 mg and 160 mg/12.5 mg contains iron oxide red and iron oxide yellow, the 160 mg/25 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 320 mg/12.5 mg contains iron oxide black and iron oxide red, and the 320 mg/25 mg contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>63187-571-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (63187-571-90) </PackageDescription>
    <NDC11Code>63187-0571-90</NDC11Code>
    <ProductNDC>63187-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130321</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202519</ApplicationNumber>
    <LabelerName>Proficient Rx LP</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-11-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Valsartan and hydrochlorothiazide tablets, USP 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 hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets, USP. 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 have also 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 (e.g., 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. Add-On TherapyValsartan and hydrochlorothiazide tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.Replacement TherapyValsartan and hydrochlorothiazide tablets, USP may be substituted for the titrated components.Initial TherapyValsartan and hydrochlorothiazide tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.The choice of valsartan and hydrochlorothiazide tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks.Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient's risk.Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with valsartan and hydrochlorothiazide tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets, USP 320 mg/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on valsartan and hydrochlorothiazide tablets, USP rise to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and hydrochlorothiazide is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan USP is a white, fine hygroscopic powder. It is soluble in ethanol and methanol and practically insoluble in water.Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.Hydrochlorothiazide is a thiazide diuretic. Its molecular formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and hydrochlorothiazide tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, talc, and titanium dioxide. In addition, the 80 mg/12.5 mg and 160 mg/12.5 mg contains iron oxide red and iron oxide yellow, the 160 mg/25 mg contains iron oxide black, iron oxide red, and iron oxide yellow, 320 mg/12.5 mg contains iron oxide black and iron oxide red, and the 320 mg/25 mg contains iron oxide yellow.</Description>
  </NDC>
  <NDC>
    <NDCCode>77335-001-45</NDCCode>
    <PackageDescription>7.571 L in 1 CAN (77335-001-45) </PackageDescription>
    <NDC11Code>77335-0001-45</NDC11Code>
    <ProductNDC>77335-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>W.r.lulus Rinse-free Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethanol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200512</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Lulus import and export co., ltd</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>73.7</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand sanitize to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>47781-729-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (47781-729-02)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>47781-0729-02</NDC11Code>
    <ProductNDC>47781-729</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120409</StartMarketingDate>
    <EndMarketingDate>20250101</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065490</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120409</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250101</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use.  Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections.  Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&amp;C Blue No. 1, D &amp; C Red No. 28, D &amp; C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-729-50</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOTTLE (47781-729-50) </PackageDescription>
    <NDC11Code>47781-0729-50</NDC11Code>
    <ProductNDC>47781-729</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120409</StartMarketingDate>
    <EndMarketingDate>20250101</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065490</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>125</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120409</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use.  Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections.  Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&amp;C Blue No. 1, D &amp; C Red No. 28, D &amp; C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-730-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (47781-730-02)  / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>47781-0730-02</NDC11Code>
    <ProductNDC>47781-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120409</StartMarketingDate>
    <EndMarketingDate>20240901</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065490</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120409</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use.  Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections.  Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&amp;C Blue No. 1, D &amp; C Red No. 28, D &amp; C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>47781-730-50</NDCCode>
    <PackageDescription>50 CAPSULE in 1 BOTTLE (47781-730-50) </PackageDescription>
    <NDC11Code>47781-0730-50</NDC11Code>
    <ProductNDC>47781-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120409</StartMarketingDate>
    <EndMarketingDate>20240901</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065490</ApplicationNumber>
    <LabelerName>Alvogen Inc.</LabelerName>
    <SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20120409</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240901</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Vancomycin hydrochloride capsules are indicated for the treatment of Clostridioides difficile-associated diarrhea. Vancomycin hydrochloride capsules are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adult and pediatric patients lessthan 18 years of age. Limitations of Use.  Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin hydrochloride capsules must be given orally for these infections.  Orally administered vancomycin hydrochloride capsules are not effective for other types ofinfections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride capsules and other antibacterial drugs, vancomycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Vancomycin hydrochloride capsules, USP for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66H75Cl2N9O24HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol. Each capsule contains 125 mg vancomycin (equivalent to 128 mg vancomycin hydrochloride) or 250 mg vancomycin (equivalent to 256 mg vancomycin hydrochloride). Inactive ingredient includes polyethylene glycol. The 125 mg capsule shell contains gelatin, FD&amp;C Blue No. 1, D &amp; C Red No. 28, D &amp; C Yellow No.10, titanium dioxide, iron oxide red and iron oxide yellow. The capsules are printed with black ink. The black imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. The 250 mg capsule shell contains gelatin, black iron oxide, iron oxide red, iron oxide yellow and titanium oxide. The capsules are printed with white ink. The white imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and titanium dioxide. Vancomycin hydrochloride has the structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3193-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3193-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3193-11</NDC11Code>
    <ProductNDC>0264-3193</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefepime Hydrochloride And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefepime Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100506</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050821</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms: : 1 Pneumonia (1.1) , 2 Empiric therapy for febrile neutropenic patients (1.2) , 3 Uncomplicated and complicated urinary tract infections (1.3) , 4 Uncomplicated skin and skin structure infections (1.4), 5 Complicated intra-abdominal infections (used in combination with metronidazole) (1.5).</IndicationAndUsage>
    <Description>Cefepime hydrochloride, USP is a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula. Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C19H25ClN6O5S2HClH2O. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® dual chamber container is supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection USP and Dextrose Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of cefepime hydrochloride with L-arginine (drug chamber) and 50 mL of 5% dextrose injection (diluent) in the DUPLEX® sterile container. The powder chamber of the DUPLEX® container contains a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefepime (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the reconstituted solution at 4.0 - 6.0. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Its empirical formula is C6H12O6H2O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula. The DUPLEX® container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. Each 50 mL contains cefepime hydrochloride equivalent to either 1 gram or 2 grams of cefepime. Reconstituted solutions of Cefepime for Injection USP and Dextrose Injection USP range in color from colorless to amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-3195-11</NDCCode>
    <PackageDescription>24 CONTAINER in 1 CASE (0264-3195-11)  / 50 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-3195-11</NDC11Code>
    <ProductNDC>0264-3195</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefepime Hydrochloride And Dextrose</ProprietaryName>
    <NonProprietaryName>Cefepime Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20100506</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050821</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefepime for Injection and Dextrose Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms: : 1 Pneumonia (1.1) , 2 Empiric therapy for febrile neutropenic patients (1.2) , 3 Uncomplicated and complicated urinary tract infections (1.3) , 4 Uncomplicated skin and skin structure infections (1.4), 5 Complicated intra-abdominal infections (used in combination with metronidazole) (1.5).</IndicationAndUsage>
    <Description>Cefepime hydrochloride, USP is a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula. Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C19H25ClN6O5S2HClH2O. Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C19H24N6O5S2) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection USP and Dextrose Injection USP in the DUPLEX® dual chamber container is supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime. Cefepime for Injection USP and Dextrose Injection USP is supplied as a sterile, nonpyrogenic, single-dose packaged combination of cefepime hydrochloride with L-arginine (drug chamber) and 50 mL of 5% dextrose injection (diluent) in the DUPLEX® sterile container. The powder chamber of the DUPLEX® container contains a sterile, dry mixture of cefepime hydrochloride and L-arginine. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent of the labeled amount of cefepime (C19H24N6O5S2). The L-arginine, at an approximate concentration of 725 mg/g of cefepime, is added to control the pH of the reconstituted solution at 4.0 - 6.0. The diluent chamber contains Dextrose Injection USP, an iso-osmotic diluent using Hydrous Dextrose USP in Water for Injection USP. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Its empirical formula is C6H12O6H2O and its molecular weight is 198.17. Hydrous Dextrose USP has the following structural (molecular) formula. The DUPLEX® container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use. Each 50 mL contains cefepime hydrochloride equivalent to either 1 gram or 2 grams of cefepime. Reconstituted solutions of Cefepime for Injection USP and Dextrose Injection USP range in color from colorless to amber. The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container is supported by USP biological evaluation procedures.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-1301-41</NDCCode>
    <PackageDescription>24 BAG in 1 BOX (0338-1301-41)  / 50 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-1301-41</NDC11Code>
    <ProductNDC>0338-1301</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefepime</ProprietaryName>
    <NonProprietaryName>Cefepime</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20080805</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050817</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia (1.1); empiric therapy for febrile neutropenic patients (1.2); uncomplicated and complicated urinary tract infections (1.3); uncomplicated skin and skin structure infections (1.4); and complicated intra-abdominal infections (used in combination with metronidazole) (1.5). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
    <Description>Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula. Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C19H25ClN6O5S2HClH2O. Cefepime Injection in Galaxy Container is a frozen, iso-osmotic, sterile, non-pyrogenic premixed solution supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime [see Dosage and Administration (2)]. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C19H24N6O5S2). The solution is intended for intravenous use after thawing to room temperature. The components and dosage formulations are given in the table below:. Cefepime Injection will range in color from colorless to amber. The plastic container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>0338-1301-48</NDCCode>
    <PackageDescription>12 BAG in 1 BOX (0338-1301-48)  / 100 mL in 1 BAG</PackageDescription>
    <NDC11Code>00338-1301-48</NDC11Code>
    <ProductNDC>0338-1301</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cefepime</ProprietaryName>
    <NonProprietaryName>Cefepime</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20080805</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050817</ApplicationNumber>
    <LabelerName>Baxter Healthcare Corporation</LabelerName>
    <SubstanceName>CEFEPIME HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/50mL</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia (1.1); empiric therapy for febrile neutropenic patients (1.2); uncomplicated and complicated urinary tract infections (1.3); uncomplicated skin and skin structure infections (1.4); and complicated intra-abdominal infections (used in combination with metronidazole) (1.5). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6).</IndicationAndUsage>
    <Description>Cefepime Injection in Galaxy Container is a sterile, injectable product consisting of Cefepime Hydrochloride, USP, a semi-synthetic, broad spectrum, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride, 72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula. Cefepime hydrochloride (monohydrate) has a molecular mass of 571.50 and a molecular formula of C19H25ClN6O5S2HClH2O. Cefepime Injection in Galaxy Container is a frozen, iso-osmotic, sterile, non-pyrogenic premixed solution supplied for intravenous administration in strengths equivalent to 1 g and 2 g of cefepime [see Dosage and Administration (2)]. It contains the equivalent of not less than 90 percent and not more than 115 percent of the labeled amount of cefepime (C19H24N6O5S2). The solution is intended for intravenous use after thawing to room temperature. The components and dosage formulations are given in the table below:. Cefepime Injection will range in color from colorless to amber. The plastic container is fabricated from a specially designed multilayer plastic. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.</Description>
  </NDC>
  <NDC>
    <NDCCode>10202-571-46</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (10202-571-46)  &gt; 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>10202-0571-46</NDC11Code>
    <ProductNDC>10202-571</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>7 Select Allergy Relief</ProprietaryName>
    <NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140417</StartMarketingDate>
    <EndMarketingDate>20200731</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076447</ApplicationNumber>
    <LabelerName>7-Eleven</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>180</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20170417</StartMarketingDatePackage>
    <EndMarketingDatePackage>20200731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>10356-571-05</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE, PUMP (10356-571-05)</PackageDescription>
    <NDC11Code>10356-0571-05</NDC11Code>
    <ProductNDC>10356-571</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nivea For Men Q10 Energy</ProprietaryName>
    <NonProprietaryName>Avobenzone, Octinoxate, Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130315</StartMarketingDate>
    <EndMarketingDate>20171130</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Beiersdorf Inc</LabelerName>
    <SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>2.5; 7; 3</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2017-12-07</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10544-571-06</NDCCode>
    <PackageDescription>6 TABLET in 1 BOTTLE (10544-571-06)</PackageDescription>
    <NDC11Code>10544-0571-06</NDC11Code>
    <ProductNDC>10544-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenazopyridine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100512</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).</IndicationAndUsage>
    <Description>Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-571-09</NDCCode>
    <PackageDescription>9 TABLET in 1 BOTTLE (10544-571-09)</PackageDescription>
    <NDC11Code>10544-0571-09</NDC11Code>
    <ProductNDC>10544-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenazopyridine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100512</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).</IndicationAndUsage>
    <Description>Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>10544-571-12</NDCCode>
    <PackageDescription>12 TABLET in 1 BOTTLE (10544-571-12)</PackageDescription>
    <NDC11Code>10544-0571-12</NDC11Code>
    <ProductNDC>10544-571</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Phenazopyridine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100512</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
    <SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled. The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION section.).</IndicationAndUsage>
    <Description>Phenazopyridine Hydrochloride is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula. Phenazopyridine HCl tablets contain the following inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>10920-571-01</NDCCode>
    <PackageDescription>25 kg in 1 DRUM (10920-571-01)</PackageDescription>
    <NDC11Code>10920-0571-01</NDC11Code>
    <ProductNDC>10920-571</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101123</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10920-571-02</NDCCode>
    <PackageDescription>10 kg in 1 DRUM (10920-571-02)</PackageDescription>
    <NDC11Code>10920-0571-02</NDC11Code>
    <ProductNDC>10920-571</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101123</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10920-571-03</NDCCode>
    <PackageDescription>5 kg in 1 DRUM (10920-571-03)</PackageDescription>
    <NDC11Code>10920-0571-03</NDC11Code>
    <ProductNDC>10920-571</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101123</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10920-571-04</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (10920-571-04)  &gt; 25 kg in 1 BAG</PackageDescription>
    <NDC11Code>10920-0571-04</NDC11Code>
    <ProductNDC>10920-571</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20101123</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Arevipharma GmbH</LabelerName>
    <SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2022-12-22</LastUpdate>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-DEC-22</StartMarketingDatePackage>
  </NDC>
</NDCList>