RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>55513-800-99</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (55513-800-99) </PackageDescription>
    <NDC11Code>55513-0800-99</NDC11Code>
    <ProductNDC>55513-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Corlanor</ProprietaryName>
    <NonProprietaryName>Ivabradine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150420</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206143</ApplicationNumber>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150420</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1), 2 For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. (1.2).</IndicationAndUsage>
    <Description>Corlanor (ivabradine) tablets and oral solution contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5∙HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of Ivabradine. Tablets. Corlanor tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerol, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol 6000, red iron oxide, titanium dioxide, and yellow iron oxide. Oral Solution. Corlanor 5 mg/5 mL (1 mg/mL) oral solution is formulated as a sterile, preservative-free, colorless solution for oral administration. Each 5 mL ampule contains 5 mg of ivabradine, equivalent to 5.39 mg ivabradine hydrochloride, as the active ingredient. The solution contains the following inactive ingredients: maltitol and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-800-60</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (55513-800-60) </PackageDescription>
    <NDC11Code>55513-0800-60</NDC11Code>
    <ProductNDC>55513-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Corlanor</ProprietaryName>
    <NonProprietaryName>Ivabradine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150420</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206143</ApplicationNumber>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: : 1 To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. (1.1), 2 For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. (1.2).</IndicationAndUsage>
    <Description>Corlanor (ivabradine) tablets and oral solution contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C27H36N2O5∙HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure 1. Chemical Structure of Ivabradine. Tablets. Corlanor tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: colloidal silicon dioxide, glycerol, hypromellose, lactose monohydrate, magnesium stearate, maize starch, maltodextrin, polyethylene glycol 6000, red iron oxide, titanium dioxide, and yellow iron oxide. Oral Solution. Corlanor 5 mg/5 mL (1 mg/mL) oral solution is formulated as a sterile, preservative-free, colorless solution for oral administration. Each 5 mL ampule contains 5 mg of ivabradine, equivalent to 5.39 mg ivabradine hydrochloride, as the active ingredient. The solution contains the following inactive ingredients: maltitol and water.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-800-80</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (55513-800-80) </PackageDescription>
    <NDC11Code>55513-0800-80</NDC11Code>
    <ProductNDC>55513-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Corlanor</ProprietaryName>
    <NonProprietaryName>Ivabradine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150420</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206143</ApplicationNumber>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC],Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-08-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150420</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55513-100-99</NDCCode>
    <PackageDescription>1.91 mL in 1 VIAL, GLASS (55513-100-99) </PackageDescription>
    <NDC11Code>55513-0100-99</NDC11Code>
    <ProductNDC>55513-100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tezspire</ProprietaryName>
    <NonProprietaryName>Tezepelumab-ekko</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211217</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761224</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>TEZEPELUMAB</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mg/1.9mL</StrengthUnit>
    <Pharm_Classes>Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211217</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.</IndicationAndUsage>
    <Description>Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-112-99</NDCCode>
    <PackageDescription>1.91 mL in 1 SYRINGE (55513-112-99) </PackageDescription>
    <NDC11Code>55513-0112-99</NDC11Code>
    <ProductNDC>55513-112</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tezspire</ProprietaryName>
    <NonProprietaryName>Tezepelumab-ekko</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20211217</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761224</ApplicationNumber>
    <LabelerName>Amgen Inc</LabelerName>
    <SubstanceName>TEZEPELUMAB</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mg/1.9mL</StrengthUnit>
    <Pharm_Classes>Thymic Stromal Lymphopoietin Blocker [EPC], Thymic Stromal Lymphopoietin Blockers [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211217</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: : 1 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. (1.1), 2  Limitations of Use:, 3  Not for relief of acute bronchospasm or status asthmaticus. (1.1), 4 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). (1.2).</IndicationAndUsage>
    <Description>Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa. TEZSPIRE (tezepelumab-ekko) injection is a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection supplied in a single-dose vial, single-dose pre-filled syringe or single‑dose pre‑filled pen. Each single-dose vial, pre-filled syringe or pre‑filled pen delivers 1.91 mL containing 210 mg tezepelumab-ekko, glacial acetic acid (2.8 mg), L-proline (48 mg), polysorbate 80 (0.19 mg), sodium hydroxide, and water for injection. The pH is 5.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>57664-800-99</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-800-99) </PackageDescription>
    <NDC11Code>57664-0800-99</NDC11Code>
    <ProductNDC>57664-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil, Amlodipine Besylate And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161026</StartMarketingDate>
    <EndMarketingDate>20240531</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA200175</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>10; 25; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161026</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
    <Description>Olmesartan medoxomil, amlodipine and hydrochlorothiazide provided as a tablet for oral administration, is a fixed combination of olmesartan medoxomil (ARB), amlodipine (CCB), and hydrochlorothiazide (thiazide diuretic). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. The olmesartan medoxomil component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6. The amlodipine besylate component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5∙C6H6O3S. The hydrochlorothiazide component of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzo-thiazidiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2. The structural formula for olmesartan medoxomil is. The structural formula for amlodipine besylate is. The structural formula for hydrochlorothiazide is. Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets contain olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder, amlodipine besylate, a white to off-white crystalline powder, and hydrochlorothiazide, a white or practically white, crystalline powder. The molecular weights of olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide are 558.6, 567.1, and 297.7, respectively. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Each tablet of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coating contains polyvinyl alcohol, macrogol/polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (20 /5 /12.5 mg, 40 /5 /12.5 mg, 40 /5 /25 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), iron oxide red (20 /5 /12.5 mg, 40 /10 /12.5 mg, and 40 /10 /25 mg tablets), and iron oxide black (20 /5 /12.5 mg tablets).</Description>
  </NDC>
  <NDC>
    <NDCCode>59676-800-99</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59676-800-99) </PackageDescription>
    <NDC11Code>59676-0800-99</NDC11Code>
    <ProductNDC>59676-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Symtuza</ProprietaryName>
    <NonProprietaryName>Darunavir, Cobicistat, Emtricitabine, And Tenofovir Alafenamide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180717</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210455</ApplicationNumber>
    <LabelerName>Janssen Products LP</LabelerName>
    <SubstanceName>DARUNAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE</SubstanceName>
    <StrengthNumber>800; 150; 200; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180717</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: 1 who have no prior antiretroviral treatment history or, 2 who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.</IndicationAndUsage>
    <Description>SYMTUZA® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) is a fixed-dose combination tablet. : 1 Darunavir is an inhibitor of the HIV-1 protease., 2 Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family., 3 Emtricitabine, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI)., 4 Tenofovir alafenamide, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65224-800-99</NDCCode>
    <PackageDescription>1 CAPSULE in 1 POUCH (65224-800-99)</PackageDescription>
    <NDC11Code>65224-0800-99</NDC11Code>
    <ProductNDC>65224-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cedax</ProprietaryName>
    <NonProprietaryName>Ceftibuten Dihydrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19951220</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050685</ApplicationNumber>
    <LabelerName>Pernix Therapeutics, LLC</LabelerName>
    <SubstanceName>CEFTIBUTEN DIHYDRATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>69482-800-99</NDCCode>
    <PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (69482-800-99)  &gt; 120 g in 1 BOTTLE, SPRAY</PackageDescription>
    <NDC11Code>69482-0800-99</NDC11Code>
    <ProductNDC>69482-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sernivo</ProprietaryName>
    <NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208079</ApplicationNumber>
    <LabelerName>Encore Dermatology Inc.</LabelerName>
    <SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.</IndicationAndUsage>
    <Description>SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.</Description>
  </NDC>
  <NDC>
    <NDCCode>73473-800-99</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (73473-800-99) </PackageDescription>
    <NDC11Code>73473-0800-99</NDC11Code>
    <ProductNDC>73473-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216639</ApplicationNumber>
    <LabelerName>Solaris Pharma Corporation</LabelerName>
    <SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>78677-800-99</NDCCode>
    <PackageDescription>2271247 mL in 1 TANK (78677-800-99) </PackageDescription>
    <NDC11Code>78677-0800-99</NDC11Code>
    <ProductNDC>78677-800</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Purevita 80% Hand Sanitizer Gel</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200307</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Davita Chemicals, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200307</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>90041-800-99</NDCCode>
    <PackageDescription>3785 mL in 1 BOTTLE (90041-800-99) </PackageDescription>
    <NDC11Code>90041-0800-99</NDC11Code>
    <ProductNDC>90041-800</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Zap Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200715</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Beverly Pharmacy, Inc. Dba Zap Hand Sanitizer</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>hand sanitizer to decrease bacteria on the skin. recommended for repeated use. for use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55513-209-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 BOX (55513-209-10)  / .8 mL in 1 SYRINGE (55513-209-01) </PackageDescription>
    <NDC11Code>55513-0209-10</NDC11Code>
    <ProductNDC>55513-209</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20001002</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>480</StrengthNumber>
    <StrengthUnit>ug/.8mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-209-20</NDCCode>
    <PackageDescription>10 SYRINGE in 1 BOX (55513-209-20)  / .8 mL in 1 SYRINGE (55513-209-01) </PackageDescription>
    <NDC11Code>55513-0209-20</NDC11Code>
    <ProductNDC>55513-209</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20001002</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>480</StrengthNumber>
    <StrengthUnit>ug/.8mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-209-91</NDCCode>
    <PackageDescription>1 SYRINGE in 1 BOX (55513-209-91)  / .8 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>55513-0209-91</NDC11Code>
    <ProductNDC>55513-209</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20001002</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>480</StrengthNumber>
    <StrengthUnit>ug/.8mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-530-10</NDCCode>
    <PackageDescription>10 VIAL in 1 PACKAGE (55513-530-10)  / 1 mL in 1 VIAL (55513-530-01) </PackageDescription>
    <NDC11Code>55513-0530-10</NDC11Code>
    <ProductNDC>55513-530</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970519</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970519</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-530-20</NDCCode>
    <PackageDescription>10 VIAL in 1 PACKAGE (55513-530-20)  / 1 mL in 1 VIAL (55513-530-01) </PackageDescription>
    <NDC11Code>55513-0530-20</NDC11Code>
    <ProductNDC>55513-530</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970519</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-546-10</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (55513-546-10)  / 1.6 mL in 1 VIAL (55513-546-01) </PackageDescription>
    <NDC11Code>55513-0546-10</NDC11Code>
    <ProductNDC>55513-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970407</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>480</StrengthNumber>
    <StrengthUnit>ug/1.6mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19970407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-546-20</NDCCode>
    <PackageDescription>10 VIAL in 1 BOX (55513-546-20)  / 1.6 mL in 1 VIAL (55513-546-01) </PackageDescription>
    <NDC11Code>55513-0546-20</NDC11Code>
    <ProductNDC>55513-546</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970407</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>480</StrengthNumber>
    <StrengthUnit>ug/1.6mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-924-10</NDCCode>
    <PackageDescription>10 SYRINGE in 1 BOX (55513-924-10)  / .5 mL in 1 SYRINGE (55513-924-01) </PackageDescription>
    <NDC11Code>55513-0924-10</NDC11Code>
    <ProductNDC>55513-924</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20001002</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-924-20</NDCCode>
    <PackageDescription>10 SYRINGE in 1 BOX (55513-924-20)  / .5 mL in 1 SYRINGE (55513-924-01) </PackageDescription>
    <NDC11Code>55513-0924-20</NDC11Code>
    <ProductNDC>55513-924</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20001002</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-924-91</NDCCode>
    <PackageDescription>1 SYRINGE in 1 BOX (55513-924-91)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>55513-0924-91</NDC11Code>
    <ProductNDC>55513-924</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neupogen</ProprietaryName>
    <NonProprietaryName>Filgrastim</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20001002</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103353</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>FILGRASTIM</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>ug/.5mL</StrengthUnit>
    <Pharm_Classes>Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001002</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>NEUPOGEN is a leukocyte growth factor indicated to: 1 Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever (1.1), 2 Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) (1.2), 3 Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (1.3), 4 Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis (1.4), 5 Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia (1.5), 6 Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) (1.6).</IndicationAndUsage>
    <Description>Filgrastim is a human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology. Filgrastim is produced by Escherichia coli (E. coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. Filgrastim has a molecular weight of 18,800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E. coli. Because filgrastim is produced in E. coli, the product is non-glycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN (filgrastim) injection is a sterile, preservative-free, clear, and colorless liquid containing filgrastim at a specific activity of 1.0 ± 0.6 × 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-dose vials and single-dose prefilled syringes for subcutaneous use or intravenous use . The single-dose vials contain either 300 mcg/mL or 480 mcg/1.6 mL of filgrastim. The single-dose prefilled syringes contain either 300 mcg/0.5 mL or 480 mcg/0.8 mL of filgrastim. The NEUPOGEN drug product has a pH of 4.0. See table below for product composition of each single-dose vial or prefilled syringe.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-3083-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (0006-3083-01)  / 2.4 mL in 1 VIAL (0006-3083-99) </PackageDescription>
    <NDC11Code>00006-3083-01</NDC11Code>
    <ProductNDC>0006-3083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Keytruda Qlex</ProprietaryName>
    <NonProprietaryName>Pembrolizumab And Berahyaluronidase Alfa-pmph</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250919</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761467</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>PEMBROLIZUMAB; BERAHYALURONIDASE ALFA</SubstanceName>
    <StrengthNumber>165; 2000</StrengthNumber>
    <StrengthUnit>mg/mL; U/mL</StrengthUnit>
    <Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).</IndicationAndUsage>
    <Description>KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9.</Description>
  </NDC>
  <NDC>
    <NDCCode>0006-5083-01</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (0006-5083-01)  / 4.8 mL in 1 VIAL (0006-5083-99) </PackageDescription>
    <NDC11Code>00006-5083-01</NDC11Code>
    <ProductNDC>0006-5083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Keytruda Qlex</ProprietaryName>
    <NonProprietaryName>Pembrolizumab And Berahyaluronidase Alfa-pmph</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250919</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761467</ApplicationNumber>
    <LabelerName>Merck Sharp &amp; Dohme LLC</LabelerName>
    <SubstanceName>PEMBROLIZUMAB; BERAHYALURONIDASE ALFA</SubstanceName>
    <StrengthNumber>165; 2000</StrengthNumber>
    <StrengthUnit>mg/mL; U/mL</StrengthUnit>
    <Pharm_Classes>Endoglycosidase [EPC], Glycoside Hydrolases [CS], Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated:. Melanoma: 1 for the treatment of adult patients with unresectable or metastatic melanoma. (1.1), 2 for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. (1.1).</IndicationAndUsage>
    <Description>KEYTRUDA QLEX is a fixed-combination drug product containing pembrolizumab and berahyaluronidase alfa. Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells. Berahyaluronidase alfa is an endoglycosidase used to enhance dispersion and permeation, which facilitates delivery of increased volume of pembrolizumab that is co-administered subcutaneously. It is produced by mammalian CHO (Chinese Hamster Ovary) cells containing a DNA plasmid encoding a variant of human hyaluronidase PH20. It is a glycosylated protein with an approximate molecular weight of 49 kDa under nonreducing, deglycosylated conditions. KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution supplied in single-dose vials for subcutaneous administration. KEYTRUDA QLEX is supplied as two different configurations: : 1 Each KEYTRUDA QLEX 2.4 mL single-dose vial contains 395 mg of pembrolizumab and 4,800 units of berahyaluronidase alfa, and histidine (0.7 mg), histidine hydrochloride monohydrate (4.1 mg), methionine (3.6 mg), polysorbate 80 (0.5 mg), sucrose (168 mg), and Water for Injection, USP. The pH is 5.3-5.9. , 2 Each KEYTRUDA QLEX 4.8 mL single-dose vial contains 790 mg of pembrolizumab and 9,600 units of berahyaluronidase alfa, and histidine (1.4 mg), histidine hydrochloride monohydrate (8.2 mg), methionine (7.2 mg), polysorbate 80 (1 mg), sucrose (336 mg), and Water for Injection, USP. The pH is 5.3-5.9.</Description>
  </NDC>
  <NDC>
    <NDCCode>0093-8305-99</NDCCode>
    <PackageDescription>16484 TABLET, FILM COATED in 1 PAIL (0093-8305-99) </PackageDescription>
    <NDC11Code>00093-8305-99</NDC11Code>
    <ProductNDC>0093-8305</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Cimetidine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <StartMarketingDate>20230330</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>CIMETIDINE</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-09-28</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-MAR-23</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>10685-520-17</NDCCode>
    <PackageDescription>800 mL in 1 BAG (10685-520-17) </PackageDescription>
    <NDC11Code>10685-0520-17</NDC11Code>
    <ProductNDC>10685-520</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Clean N Fresh Instant Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20001001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Carroll Company</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.62</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20001001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to sanitize hands without requiring water or a rinse. kills 99.9% of most common bacteria in 15 seconds.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>12634-682-99</NDCCode>
    <PackageDescription>9 TABLET in 1 BOTTLE (12634-682-99)</PackageDescription>
    <NDC11Code>12634-0682-99</NDC11Code>
    <ProductNDC>12634-682</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ibuprofen</ProprietaryName>
    <NonProprietaryName>Ibuprofen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075682</ApplicationNumber>
    <LabelerName>Apotheca, Inc.</LabelerName>
    <SubstanceName>IBUPROFEN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>16837-840-99</NDCCode>
    <PackageDescription>21000 TABLET, CHEWABLE in 1 DRUM (16837-840-99) </PackageDescription>
    <NDC11Code>16837-0840-99</NDC11Code>
    <ProductNDC>16837-840</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Famotidine, Calcium Carbonate, And Magnesium Hydroxide</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <StartMarketingDate>20190501</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Kenvue Brands LLC</LabelerName>
    <SubstanceName>FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE</SubstanceName>
    <StrengthNumber>800; 10; 165</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-07-29</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>10-JAN-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>33261-116-99</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (33261-116-99)</PackageDescription>
    <NDC11Code>33261-0116-99</NDC11Code>
    <ProductNDC>33261-116</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20111006</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200651</ApplicationNumber>
    <LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>54218-800-01</NDCCode>
    <PackageDescription>1.814 kg in 1 CYLINDER (54218-800-01) </PackageDescription>
    <NDC11Code>54218-0800-01</NDC11Code>
    <ProductNDC>54218-800</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrous Oxide</ProprietaryName>
    <NonProprietaryName>Nitrous Oxide</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19700101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205704</ApplicationNumber>
    <LabelerName>United States Welding, Inc.</LabelerName>
    <SubstanceName>NITROUS OXIDE</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19700101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>