RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>84660-115-07</NDCCode>
    <PackageDescription>20 mL in 1 BOTTLE (84660-115-07) </PackageDescription>
    <NDC11Code>84660-0115-07</NDC11Code>
    <ProductNDC>84660-115</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Daswagen Wart Remover Liquid</ProprietaryName>
    <NonProprietaryName>Daswagen Wart Remover Liquid</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251001</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Guangdong Ximonth Technology Co., Ltd.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>17</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11084-115-07</NDCCode>
    <PackageDescription>2000 mL in 1 CARTRIDGE (11084-115-07)</PackageDescription>
    <NDC11Code>11084-0115-07</NDC11Code>
    <ProductNDC>11084-115</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Panache</ProprietaryName>
    <ProprietaryNameSuffix>Antibacterial Body Wash</ProprietaryNameSuffix>
    <NonProprietaryName>Triclosan</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Deb USA, Inc.</LabelerName>
    <SubstanceName>TRICLOSAN</SubstanceName>
    <StrengthNumber>.55</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Uses. For washing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>33342-115-07</NDCCode>
    <PackageDescription>30 TABLET in 1 CONTAINER (33342-115-07) </PackageDescription>
    <NDC11Code>33342-0115-07</NDC11Code>
    <ProductNDC>33342-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Candesartan</ProprietaryName>
    <NonProprietaryName>Candesartan</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161206</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203813</ApplicationNumber>
    <LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
    <SubstanceName>CANDESARTAN CILEXETIL</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-12-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161206</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Candesartan cilexetil tablets are an angiotensin II receptor blocker (ARB) indicated for. · Treatment of hypertension in adults and children 1 to &lt; 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1). ·  Treatment of heart failure (NYHA class II-IV); candesartan reduces cardiovascular death and heart failure hospitalization (1.2).</IndicationAndUsage>
    <Description>Candesartan cilexetil, USP a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT1 subtype angiotensin II receptor antagonist. Candesartan cilexetil, USP a nonpeptide, is chemically described as (±)-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester). Its molecular formula is C33H34N6O6, and its structural formula is. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil USP is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Candesartan cilexetil, USP is available for oral use as tablets containing either 4 mg, 8 mg, 16 mg, or 32 mg of candesartan cilexetil and the following inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, corn starch, glycerin, carboxymethylcellulose calcium, and magnesium stearate. Ferric oxide is added to the 8-mg, 16-mg, and 32-mg tablets as a colorant.</Description>
  </NDC>
  <NDC>
    <NDCCode>42658-115-07</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42658-115-07) </PackageDescription>
    <NDC11Code>42658-0115-07</NDC11Code>
    <ProductNDC>42658-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ticagrelor</ProprietaryName>
    <NonProprietaryName>Ticagrelor</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208575</ApplicationNumber>
    <LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
    <SubstanceName>TICAGRELOR</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, hypromellose E5, polyethylene glycol 4000, colloidal silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, polyethylene glycol 400, ferric oxide yellow, ferric oxide red, and ferrosoferric oxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>57297-115-07</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (57297-115-07)</PackageDescription>
    <NDC11Code>57297-0115-07</NDC11Code>
    <ProductNDC>57297-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090025</ApplicationNumber>
    <LabelerName>LUPIN LIMITED</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Levetiracetam tablets USP are indicated for adjunctive therapy in the treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&amp;C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&amp;C Blue No. 2/indigo carmine Aluminum Lake, FD&amp;C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>61874-115-07</NDCCode>
    <PackageDescription>7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07) </PackageDescription>
    <NDC11Code>61874-0115-07</NDC11Code>
    <ProductNDC>61874-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vraylar</ProprietaryName>
    <NonProprietaryName>Cariprazine</NonProprietaryName>
    <DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150917</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204370</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>CARIPRAZINE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160301</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>VRAYLAR® is indicated for.  Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies (14.1)].  Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see Clinical Studies (14.2)].  Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adult patients [see Clinical Studies (14.3)].  Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adult patients [see Clinical Studies (14.4)].</IndicationAndUsage>
    <Description>The active ingredient of VRAYLAR is cariprazine, an atypical antipsychotic, in hydrochloride salt form. The chemical name is trans-N-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-N’,N’-dimethylurea hydrochloride; its empirical formula is C21H32Cl2N4OHCl and its molecular weight is 463.9 g/mol. The chemical structure is. VRAYLAR capsules are intended for oral administration only. Each hard gelatin capsule contains  0.5, 0.75, 1.5, 3, 4.5, or 6 mg of cariprazine base (equivalent to 0.545 mg, 0.818 mg, 1.635 mg , 3.27 mg, 4.905 mg, or 6.54 mg cariprazine HCl). In addition, capsules include the following inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide. Colorants include black iron oxide (0.5, 0.75, 1.5, 3, and 6 mg), FD&amp;C Blue 1 (0.5, 0.75, 3, 4.5, and 6 mg), FD&amp;C Red 3 (6 mg), FD&amp;C Red 40 (3 and 4.5 mg), or yellow iron oxide (0.5, 3, and 4.5 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>63868-115-07</NDCCode>
    <PackageDescription>222 mL in 1 BOTTLE, PLASTIC (63868-115-07)</PackageDescription>
    <NDC11Code>63868-0115-07</NDC11Code>
    <ProductNDC>63868-115</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Awaken By Quality Choice Foaming Hand Wash</ProprietaryName>
    <ProprietaryNameSuffix>Spring Showers</ProprietaryNameSuffix>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>SOAP</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160818</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Chain Drug MArketing Association Inc</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>1.3</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps eliminate bacterial on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64330-115-07</NDCCode>
    <PackageDescription>.75 kg in 1 DRUM (64330-115-07) </PackageDescription>
    <NDC11Code>64330-0115-07</NDC11Code>
    <ProductNDC>64330-115</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Metolazone</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150729</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Centaur Pharmaceuticals Private Limited</LabelerName>
    <SubstanceName>METOLAZONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-07-23</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>21-JUN-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>65597-115-07</NDCCode>
    <PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (65597-115-07) </PackageDescription>
    <NDC11Code>65597-0115-07</NDC11Code>
    <ProductNDC>65597-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tribenzor</ProprietaryName>
    <NonProprietaryName>Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100731</StartMarketingDate>
    <EndMarketingDate>20230731</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA200175</ApplicationNumber>
    <LabelerName>Daiichi Sankyo, Inc.</LabelerName>
    <SubstanceName>AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL</SubstanceName>
    <StrengthNumber>5; 12.5; 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>2023-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100731</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230731</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tribenzor is 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 Tribenzor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Limitations of Use. This fixed combination drug is not indicated for the initial therapy of hypertension.</IndicationAndUsage>
    <Description>Tribenzor 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 Tribenzor 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 Tribenzor 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 C20H25ClN2O5C6H6O3S. The hydrochlorothiazide component of Tribenzor 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. Tribenzor contains 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 Tribenzor 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>68180-115-07</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (68180-115-07) </PackageDescription>
    <NDC11Code>68180-0115-07</NDC11Code>
    <ProductNDC>68180-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levetiracetam</ProprietaryName>
    <NonProprietaryName>Levetiracetam</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090025</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>LEVETIRACETAM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets USP are indicated for adjunctive therapy for  treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy (1.1), 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
    <Description>Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&amp;C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&amp;C Blue No. 2/indigo carmine Aluminum Lake, FD&amp;C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>70994-115-07</NDCCode>
    <PackageDescription>4.25 g in 1 TUBE (70994-115-07) </PackageDescription>
    <NDC11Code>70994-0115-07</NDC11Code>
    <ProductNDC>70994-115</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Pain Relief Vegan</ProprietaryName>
    <NonProprietaryName>Arnica Montana</NonProprietaryName>
    <DosageFormName>SALVE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220310</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Sierra Sage Herbs LLC</LabelerName>
    <SubstanceName>ARNICA MONTANA FLOWER</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ temporarily reief of minor aches and pains of muscles and joints associated with ■ arthritis ■ bruises ■ sprains ■ scrapes ■ strains ■ simple backache ■ sore muscles.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71894-133-07</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (71894-133-07)  *  8.3 mL in 1 VIAL (71894-115-01)  *  1 mL in 1 POUCH *  5.5 mL in 1 VIAL (71894-110-01) </PackageDescription>
    <NDC11Code>71894-0133-07</NDC11Code>
    <ProductNDC>71894-133</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolgensma</ProprietaryName>
    <NonProprietaryName>Onasemnogene Abeparvovec-xioi</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190524</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125694</ApplicationNumber>
    <LabelerName>Novartis Innovative Technologies Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Limitations of Use: 1 The safety and effectiveness of repeat administration of ZOLGENSMA have not been evaluated [see Adverse Reactions (6.2)]. , 2 The use of ZOLGENSMA in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>ZOLGENSMA is a suspension of an adeno-associated viral vector-based gene therapy for intravenous infusion. It is a recombinant self-complementary AAV9 containing a transgene encoding the human survival motor neuron (SMN) protein, under the control of a cytomegalovirus enhancer/chicken-β-actin hybrid promoter. ZOLGENSMA has a nominal concentration of 2.0 × 1013 vg/mL. Each vial contains an extractable volume of not less than either 5.5 mL or 8.3 mL and the excipients 20 mM Tris (pH 8.0), 1 mM magnesium chloride (MgCl2), 200 mM sodium chloride (NaCl) and 0.005% poloxamer 188. ZOLGENSMA is packaged as a sterile suspension and contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>71894-134-07</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (71894-134-07)  *  8.3 mL in 1 VIAL (71894-115-01)  *  1 mL in 1 POUCH *  5.5 mL in 1 VIAL (71894-110-01) </PackageDescription>
    <NDC11Code>71894-0134-07</NDC11Code>
    <ProductNDC>71894-134</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolgensma</ProprietaryName>
    <NonProprietaryName>Onasemnogene Abeparvovec-xioi</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190524</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125694</ApplicationNumber>
    <LabelerName>Novartis Innovative Technologies Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Limitations of Use: 1 The safety and effectiveness of repeat administration of ZOLGENSMA have not been evaluated [see Adverse Reactions (6.2)]. , 2 The use of ZOLGENSMA in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>ZOLGENSMA is a suspension of an adeno-associated viral vector-based gene therapy for intravenous infusion. It is a recombinant self-complementary AAV9 containing a transgene encoding the human survival motor neuron (SMN) protein, under the control of a cytomegalovirus enhancer/chicken-β-actin hybrid promoter. ZOLGENSMA has a nominal concentration of 2.0 × 1013 vg/mL. Each vial contains an extractable volume of not less than either 5.5 mL or 8.3 mL and the excipients 20 mM Tris (pH 8.0), 1 mM magnesium chloride (MgCl2), 200 mM sodium chloride (NaCl) and 0.005% poloxamer 188. ZOLGENSMA is packaged as a sterile suspension and contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>71894-135-07</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (71894-135-07)  *  8.3 mL in 1 VIAL (71894-115-01)  *  1 mL in 1 POUCH</PackageDescription>
    <NDC11Code>71894-0135-07</NDC11Code>
    <ProductNDC>71894-135</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zolgensma</ProprietaryName>
    <NonProprietaryName>Onasemnogene Abeparvovec-xioi</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20190524</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125694</ApplicationNumber>
    <LabelerName>Novartis Innovative Technologies Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190524</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Limitations of Use: 1 The safety and effectiveness of repeat administration of ZOLGENSMA have not been evaluated [see Adverse Reactions (6.2)]. , 2 The use of ZOLGENSMA in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>ZOLGENSMA is a suspension of an adeno-associated viral vector-based gene therapy for intravenous infusion. It is a recombinant self-complementary AAV9 containing a transgene encoding the human survival motor neuron (SMN) protein, under the control of a cytomegalovirus enhancer/chicken-β-actin hybrid promoter. ZOLGENSMA has a nominal concentration of 2.0 × 1013 vg/mL. Each vial contains an extractable volume of not less than either 5.5 mL or 8.3 mL and the excipients 20 mM Tris (pH 8.0), 1 mM magnesium chloride (MgCl2), 200 mM sodium chloride (NaCl) and 0.005% poloxamer 188. ZOLGENSMA is packaged as a sterile suspension and contains no preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-115-07</NDCCode>
    <PackageDescription>15 mL in 1 VIAL, GLASS (71919-115-07) </PackageDescription>
    <NDC11Code>71919-0115-07</NDC11Code>
    <ProductNDC>71919-115</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bellis</ProprietaryName>
    <NonProprietaryName>Bellis Perennis</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110517</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>ALFALFA</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110517</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>81952-115-07</NDCCode>
    <PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (81952-115-07)  / 2 mL in 1 VIAL, SINGLE-DOSE (81952-115-02) </PackageDescription>
    <NDC11Code>81952-0115-07</NDC11Code>
    <ProductNDC>81952-115</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Heparin Sodium</ProprietaryName>
    <NonProprietaryName>Heparin Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20140612</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202732</ApplicationNumber>
    <LabelerName>Hepalink USA Inc.</LabelerName>
    <SubstanceName>HEPARIN SODIUM</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[USP'U]/mL</StrengthUnit>
    <Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-02-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140612</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino- α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy- α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)&gt; (1)&gt; (4)&gt; (3)&gt; (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits):. Heparin sodium injection, USP (porcine), preservative free, is available as follows. Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; Water for Injection q.s. made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin sodium injection, USP (porcine), preserved with benzyl alcohol, is available as follows. Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 6 mg sodium chloride; 15 mg benzyl alcohol (as a preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin Sodium Injection, USP (porcine), preserved with parabens, is available as follows. Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 5 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 10,000 units per mL preparation contains: 10,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 20,000 units per mL preparation contains: 20,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5).</Description>
  </NDC>
  <NDC>
    <NDCCode>82133-115-07</NDCCode>
    <PackageDescription>.01 kg in 1 CONTAINER (82133-115-07) </PackageDescription>
    <NDC11Code>82133-0115-07</NDC11Code>
    <ProductNDC>82133-115</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Latanoprost</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <StartMarketingDate>20251201</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>C-SQUARED PHARMA LIMITED</LabelerName>
    <SubstanceName>LATANOPROST</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-DEC-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>82393-115-07</NDCCode>
    <PackageDescription>.025 kg in 1 BOTTLE, PLASTIC (82393-115-07) </PackageDescription>
    <NDC11Code>82393-0115-07</NDC11Code>
    <ProductNDC>82393-115</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Buprenorphine Hcl</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220105</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Pharma Source Direct, Inc.</LabelerName>
    <SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-08</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>05-JAN-22</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>83589-115-07</NDCCode>
    <PackageDescription>25 g in 1 BAG (83589-115-07) </PackageDescription>
    <NDC11Code>83589-0115-07</NDC11Code>
    <ProductNDC>83589-115</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Epitalon</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20250430</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
    <SubstanceName>EPITALON</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>30-APR-25</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>0049-0013-83</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0049-0013-83)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81) </PackageDescription>
    <NDC11Code>00049-0013-83</NDC11Code>
    <ProductNDC>0049-0013</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Unasyn</ProprietaryName>
    <NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19911122</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050608</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
    <StrengthNumber>1; .5</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19911122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis). While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to UNASYN. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat 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>UNASYN (ampicillin and sulbactam) for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. UNASYN is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.125 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-0014-83</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (0049-0014-83)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81) </PackageDescription>
    <NDC11Code>00049-0014-83</NDC11Code>
    <ProductNDC>0049-0014</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Unasyn</ProprietaryName>
    <NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19911122</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050608</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
    <StrengthNumber>2; 1</StrengthNumber>
    <StrengthUnit>g/1; g/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19911122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS–Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis). While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to UNASYN. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat 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>UNASYN (ampicillin and sulbactam) for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. UNASYN is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each 1.5 g vial contains ampicillin 1 g and sulbactam 0.5 g (equivalent to 1.063 g ampicillin sodium and 0.547 g sulbactam sodium). Each 1.5 g vial contains approximately 115 mg of sodium. Each 3 g vial contains ampicillin 2 g and sulbactam 1 g (equivalent to 2.125 g ampicillin sodium and 1.094 g sulbactam sodium). Each 3 g vial contains approximately 230 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0049-0024-28</NDCCode>
    <PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28)  / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
    <NDC11Code>00049-0024-28</NDC11Code>
    <ProductNDC>0049-0024</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Unasyn</ProprietaryName>
    <NonProprietaryName>Ampicillin Sodium And Sulbactam Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>19911122</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA050608</ApplicationNumber>
    <LabelerName>Roerig</LabelerName>
    <SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
    <StrengthNumber>100; 50</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19911122</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>UNASYN is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Efficacy for this organism in this organ system was studied in fewer than 10 infections. Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. NOTE: For information on use in pediatric patients (see PRECAUTIONS-Pediatric Use and CLINICAL STUDIES sections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis). While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to UNASYN. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of UNASYN and other antibacterial drugs, UNASYN should be used only to treat 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>UNASYN (ampicillin and sulbactam) for injection, USP is a sterile antibacterial fixed-combination drug product consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C16H18N3NaO4S. The structural formula is. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C8H10NNaO5S with a molecular weight of 255.22. The structural formula is. UNASYN is available as a white to off-white dry powder for reconstitution. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. UNASYN pharmacy bulk package is a vial containing a sterile preparation for parenteral use. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of UNASYN for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR USE–Directions for Proper Use of Pharmacy Bulk Package section). Each 15 g vial contains ampicillin 10 g and sulbactam 5 g (equivalent to 10.627 g ampicillin sodium and 5.470 g sulbactam sodium). Each 1.5 g of UNASYN contains approximately 115 mg of sodium.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0326-56</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0054-0326-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>00054-0326-56</NDC11Code>
    <ProductNDC>0054-0326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20201217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203433</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50; 100</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
    <Description>Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure. Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0327-56</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0054-0327-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>00054-0327-56</NDC11Code>
    <ProductNDC>0054-0327</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20201217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203433</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50; 250</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201217</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
    <Description>Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure. Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>0054-0328-56</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0054-0328-56)  / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>00054-0328-56</NDC11Code>
    <ProductNDC>0054-0328</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20201217</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203433</ApplicationNumber>
    <LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50; 500</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
    <Description>Fluticasone propionate and salmeterol inhalation powder USP, 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder USP, 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder USP, 500 mcg/50 mcg are combinations of fluticasone propionate, USP and salmeterol xinafoate, USP. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-fluoromethyl-6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate and the following chemical structure. Fluticasone propionate is a white or almost white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 1,3-benzenedimethanol, 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-(±)-,1-hydroxy-2-naphthalenecarboxylate (salt) and the following chemical structure. Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.75, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is in a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 mcg, 250 mcg, or 500 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 mcg, 233 mcg, and 465 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg, fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, and fluticasone propionate and salmeterol inhalation powder 500 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4‑year‑old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8‑year‑old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</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>0409-0040-10</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 CARTON (0409-0040-10)  / 5 mL in 1 VIAL, MULTI-DOSE (0409-0040-05) </PackageDescription>
    <NDC11Code>00409-0040-10</NDC11Code>
    <ProductNDC>0409-0040</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ketamine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ketamine Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20221010</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074549</ApplicationNumber>
    <LabelerName>Hospira, Inc.</LabelerName>
    <SubstanceName>KETAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
    <DEASchedule>CIII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ketamine Hydrochloride Injection is indicated: 1 as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation., 2 for the induction of anesthesia prior to the administration of other general anesthetic agents., 3 as a supplement to other anesthetic agents.</IndicationAndUsage>
    <Description>Ketamine Hydrochloride Injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular formula of C13H16ClNOHCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is (±)-2-(o-Chlorophenyl)-2-(methylamino)cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is. It is formulated as a slightly acidic (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection. Each milliliter (mL) of the multiple-dose vials contains 100 mg ketamine base (equivalent to 115.3 mg ketamine hydrochloride) and not more than 0.10 mg/mL benzethonium chloride added as a preservative in water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-6010-06</NDCCode>
    <PackageDescription>1 INHALER in 1 CARTON (0527-6010-06)  / 60 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>00527-6010-06</NDC11Code>
    <ProductNDC>0527-6010</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20260112</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214464</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50; 100</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
    <Description>Fluticasone Propionate and Salmeterol Inhalation Powder USP 100 mcg/50 mcg and 250 mcg/50 mcg, is a mixture of fluticasone propionate and salmeterol xinafoate for use in dry powder inhalers. The Inhalation Powder contains NLT 90% and NMT 110% of the labeled amount of fluticasone propionate (C25H31F3O5S) and NLT 90% and NMT 110% of the labeled amount of salmeterol (C25H37NO4) as salmeterol xinafoate. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 or 250 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 and 233 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg and fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
  <NDC>
    <NDCCode>0527-6011-06</NDCCode>
    <PackageDescription>1 INHALER in 1 CARTON (0527-6011-06)  / 60 POWDER in 1 INHALER</PackageDescription>
    <NDC11Code>00527-6011-06</NDC11Code>
    <ProductNDC>0527-6011</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluticasone Propionate And Salmeterol</ProprietaryName>
    <NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20241129</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214464</ApplicationNumber>
    <LabelerName>Lannett Company, Inc.</LabelerName>
    <SubstanceName>SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE</SubstanceName>
    <StrengthNumber>50; 250</StrengthNumber>
    <StrengthUnit>ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260112</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluticasone propionate and salmeterol inhalation powder is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for: 1 Twice-daily treatment of asthma in patients aged 4 years and older. (1.1), 2 Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2).</IndicationAndUsage>
    <Description>Fluticasone Propionate and Salmeterol Inhalation Powder USP 100 mcg/50 mcg and 250 mcg/50 mcg, is a mixture of fluticasone propionate and salmeterol xinafoate for use in dry powder inhalers. The Inhalation Powder contains NLT 90% and NMT 110% of the labeled amount of fluticasone propionate (C25H31F3O5S) and NLT 90% and NMT 110% of the labeled amount of salmeterol (C25H37NO4) as salmeterol xinafoate. One active component of fluticasone propionate and salmeterol inhalation powder is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate, 17-propionate and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. The other active component of fluticasone propionate and salmeterol inhalation powder is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. Fluticasone propionate and salmeterol inhalation powder is a gray plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized fluticasone propionate (100 or 250 mcg) and micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, fluticasone propionate and salmeterol inhalation powder delivers 93 and 233 mcg of fluticasone propionate and 45 mcg of salmeterol base per blister from fluticasone propionate and salmeterol inhalation powder 100 mcg/50 mcg and fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, respectively, when tested at a flow rate of 60 L/min for 2 seconds. In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through another dry powder inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min). Inhalation profiles for adolescent (N = 13, aged 12 to 17 years) and adult (N = 17, aged 18 to 50 years) subjects with asthma inhaling maximally through another dry powder inhaler show mean PIF of 122.2 L/min (range: 81.6 to 152.1 L/min). Inhalation profiles for pediatric subjects with asthma inhaling maximally through another dry powder inhaler show a mean PIF of 75.5 L/min (range: 49.0 to 104.8 L/min) for the 4-year-old subject set (N = 20) and 107.3 L/min (range: 82.8 to 125.6 L/min) for the 8-year-old subject set (N = 20). The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.</Description>
  </NDC>
</NDCList>