RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>0781-6355-87</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0781-6355-87)  &gt; 120 SPRAY, METERED in 1 BOTTLE, PUMP</PackageDescription>
    <NDC11Code>00781-6355-87</NDC11Code>
    <ProductNDC>0781-6355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mometasone Furoate Monohydrate</ProprietaryName>
    <NonProprietaryName>Mometasone Furoate Monohydrate</NonProprietaryName>
    <DosageFormName>SPRAY, METERED</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20160325</StartMarketingDate>
    <EndMarketingDate>20211031</EndMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020762</ApplicationNumber>
    <LabelerName>Sandoz Inc.</LabelerName>
    <SubstanceName>MOMETASONE FUROATE MONOHYDRATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2021-11-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20160325</StartMarketingDatePackage>
    <EndMarketingDatePackage>20211031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0781-5948-87</NDCCode>
    <PackageDescription>14000 TABLET, FILM COATED in 1 BOTTLE (0781-5948-87)</PackageDescription>
    <NDC11Code>00781-5948-87</NDC11Code>
    <ProductNDC>0781-5948</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Valsartan And Hydrochlorothiazide</ProprietaryName>
    <NonProprietaryName>Valsartan And Hydrochlorothiazide</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20120921</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA020818</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>VALSARTAN; HYDROCHLOROTHIAZIDE</SubstanceName>
    <StrengthNumber>80; 12.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Valsartan and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension, to lower blood pressure.  Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs.  There are no controlled trials demonstrating risk reduction with Valsartan and Hydrochlorothiazide Tablets, USP. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Add-On Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Replacement Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components. Initial Therapy. Valsartan and Hydrochlorothiazide Tablets, USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals. The choice of Valsartan and Hydrochlorothiazide Tablets, USP as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk. Data from the high dose multifactorial trial [see Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Valsartan and Hydrochlorothiazide Tablets, USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures. For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of &lt;140 mmHg (systolic) and 60% likelihood of achieving &lt;90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on hydrochlorothiazide alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Valsartan and Hydrochlorothiazide Tablets, USP rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).</IndicationAndUsage>
    <Description>Valsartan and Hydrochlorothiazide Tablets, USP are a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic. Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is. Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is. Valsartan and Hydrochlorothiazide Tablets, USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg, and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-6184-87</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (0781-6184-87)  / 5 CONTAINER in 1 POUCH (0781-6184-14)  / .3 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00781-6184-87</NDC11Code>
    <ProductNDC>0781-6184</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tafluprost</ProprietaryName>
    <NonProprietaryName>Tafluprost</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20221205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209040</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>TAFLUPROST</SubstanceName>
    <StrengthNumber>.0045</StrengthNumber>
    <StrengthUnit>mg/.3mL</StrengthUnit>
    <Pharm_Classes>Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tafluprost ophthalmic solution is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Tafluprost ophthalmic solution 0.0015% contains tafluprost, a fluorinated analog of prostaglandin F2α, for topical ophthalmic use. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R, 2R, 3R, 5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.53. Its structural formula is. Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water. Tafluprost ophthalmic solution 0.0015% is supplied as a sterile solution with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmo/kg. Tafluprost ophthalmic solution contains. Active: tafluprost 0.015 mg/mL. Inactive: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. Tafluprost ophthalmic solution does not contain a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-7077-87</NDCCode>
    <PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (0781-7077-87)  / 70 g in 1 TUBE, WITH APPLICATOR</PackageDescription>
    <NDC11Code>00781-7077-87</NDC11Code>
    <ProductNDC>0781-7077</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Metronidazole</ProprietaryName>
    <NonProprietaryName>Metronidazole</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>VAGINAL</RouteName>
    <StartMarketingDate>20061031</StartMarketingDate>
    <EndMarketingDate>20241130</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077264</ApplicationNumber>
    <LabelerName>Sandoz Inc.</LabelerName>
    <SubstanceName>METRONIDAZOLE</SubstanceName>
    <StrengthNumber>7.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20061031</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Metronidazole vaginal gel USP, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). : 1 NOTE: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.</IndicationAndUsage>
    <Description>Metronidazole vaginal gel USP, 0.75% is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C6H9N3O3, a molecular weight of 171.16, and has the following structure. Metronidazole vaginal gel USP, 0.75% is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 5.5. The gel also contains carbopol 974P, edetate disodium, methylparaben, propylene glycol, propylparaben and sodium hydroxide. Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-7146-87</NDCCode>
    <PackageDescription>1 POUCH in 1 CARTON (0781-7146-87)  &gt; 30 AMPULE in 1 POUCH &gt; 3 mL in 1 AMPULE</PackageDescription>
    <NDC11Code>00781-7146-87</NDC11Code>
    <ProductNDC>0781-7146</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20130520</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202496</ApplicationNumber>
    <LabelerName>Sandoz Inc.</LabelerName>
    <SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>.5; 3</StrengthNumber>
    <StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0781-7515-87</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (0781-7515-87)  / 5 AMPULE in 1 POUCH (0781-7515-14)  / 2 mL in 1 AMPULE (0781-7515-72) </PackageDescription>
    <NDC11Code>00781-7515-87</NDC11Code>
    <ProductNDC>0781-7515</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Budesonide</ProprietaryName>
    <NonProprietaryName>Budesonide</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20150724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201966</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Budesonide inhalation suspension is an inhaled corticosteroid indicated for: 1 Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1).</IndicationAndUsage>
    <Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide inhalation suspension is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, sodium citrate dihydrate and water for injection. Three dose strengths are available in single-dose ampules: 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-7516-87</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (0781-7516-87)  / 5 AMPULE in 1 POUCH (0781-7516-14)  / 2 mL in 1 AMPULE (0781-7516-72) </PackageDescription>
    <NDC11Code>00781-7516-87</NDC11Code>
    <ProductNDC>0781-7516</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Budesonide</ProprietaryName>
    <NonProprietaryName>Budesonide</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20150724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201966</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Budesonide inhalation suspension is an inhaled corticosteroid indicated for: 1 Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1).</IndicationAndUsage>
    <Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide inhalation suspension is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, sodium citrate dihydrate and water for injection. Three dose strengths are available in single-dose ampules: 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-7517-87</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (0781-7517-87)  / 5 AMPULE in 1 POUCH (0781-7517-14)  / 2 mL in 1 AMPULE (0781-7517-72) </PackageDescription>
    <NDC11Code>00781-7517-87</NDC11Code>
    <ProductNDC>0781-7517</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Budesonide</ProprietaryName>
    <NonProprietaryName>Budesonide</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20150724</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201966</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>BUDESONIDE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/2mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150724</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Budesonide inhalation suspension is an inhaled corticosteroid indicated for: 1 Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age (1).</IndicationAndUsage>
    <Description>Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide inhalation suspension is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 103. Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, sodium citrate dihydrate and water for injection. Three dose strengths are available in single-dose ampules: 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration (2)].</Description>
  </NDC>
  <NDC>
    <NDCCode>50474-781-87</NDCCode>
    <PackageDescription>2 SYRINGE, GLASS in 1 CARTON (50474-781-87)  / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
    <NDC11Code>50474-0781-87</NDC11Code>
    <ProductNDC>50474-781</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bimzelx</ProprietaryName>
    <NonProprietaryName>Bimekizumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20231017</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761151</ApplicationNumber>
    <LabelerName>UCB, Inc.</LabelerName>
    <SubstanceName>BIMEKIZUMAB</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis (PSO)in adults who are candidates for systemic therapy or phototherapy. ( 1.1) , 2 Adults with active psoriatic arthritis (PsA). ( 1.2) , 3 Adults with active non-radiographic axial spondyloarthritis( nr-axSpA) with objective signs of inflammation. ( 1.3) , 4 Adults with active ankylosing spondylitis( AS). ( 1.4) , 5 Adults with moderate to severe hidradenitis suppurativa (HS). ( 1.5) .</IndicationAndUsage>
    <Description>Bimekizumab-bkzx, an interleukin-17 A and F antagonist, is a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody. Bimekizumab-bkzx is produced by recombinant DNA technology in Chinese Hamster Ovary cells, and has an approximate molecular weight of 150 kDa. BIMZELX (bimekizumab-bkzx) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to pale brownish-yellow solution for subcutaneous use. Each BIMZELX 1 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 1 mL containing 160 mg bimekizumab-bkzx, glacial acetic acid (1.23 mg), glycine (16.5 mg), polysorbate 80 (0.4 mg), sodium acetate (2.83 mg), and Water for Injection, USP at pH 5.1. Each BIMZELX 2 mL (160 mg/mL) prefilled syringe or prefilled autoinjector delivers 2 mL containing 320 mg bimekizumab-bkzx, glacial acetic acid (2.46 mg), glycine (33.0 mg), polysorbate 80 (0.8 mg), sodium acetate (5.65 mg), and Water for Injection, USP at pH 5.1.</Description>
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  <NDC>
    <NDCCode>0781-2855-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (0781-2855-05) </PackageDescription>
    <NDC11Code>00781-2855-05</NDC11Code>
    <ProductNDC>0781-2855</ProductNDC>
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    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
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    <LastUpdate>2024-07-31</LastUpdate>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0781-2855-31</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0781-2855-31) </PackageDescription>
    <NDC11Code>00781-2855-31</NDC11Code>
    <ProductNDC>0781-2855</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
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    <StartMarketingDate>19971022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074655</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
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    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0781-2855-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (0781-2855-60) </PackageDescription>
    <NDC11Code>00781-2855-60</NDC11Code>
    <ProductNDC>0781-2855</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
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    <StartMarketingDate>19971022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074655</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0781-2855-92</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (0781-2855-92) </PackageDescription>
    <NDC11Code>00781-2855-92</NDC11Code>
    <ProductNDC>0781-2855</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
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    <StartMarketingDate>19971022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074655</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2865-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (0781-2865-05) </PackageDescription>
    <NDC11Code>00781-2865-05</NDC11Code>
    <ProductNDC>0781-2865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
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    <DosageFormName>CAPSULE</DosageFormName>
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    <StartMarketingDate>19971022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074655</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
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    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2865-31</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (0781-2865-31) </PackageDescription>
    <NDC11Code>00781-2865-31</NDC11Code>
    <ProductNDC>0781-2865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
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    <DosageFormName>CAPSULE</DosageFormName>
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    <StartMarketingDate>19971022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074655</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-2865-92</NDCCode>
    <PackageDescription>90 CAPSULE in 1 BOTTLE (0781-2865-92) </PackageDescription>
    <NDC11Code>00781-2865-92</NDC11Code>
    <ProductNDC>0781-2865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine Hydrochloride</ProprietaryName>
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    <DosageFormName>CAPSULE</DosageFormName>
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    <StartMarketingDate>19971022</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074655</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971022</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine hydrochloride is indicated in: 1 1.Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 2.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative trials have been carried out for periods of longer than 1 year., 3 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 4.Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 5.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled trials have been carried out for 1 year., 6 6.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine hydrochloride 150 mg two times a day., 7 7.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine hydrochloride 150 mg 4 times daily., 8 8.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>Ranitidine hydrochloride (HCl), USP is a histamine H2-receptor antagonist. Chemically it is N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure. The molecular formula is C13H22N4O3S  HCl, representing a molecular weight of 350.87. Ranitidine hydrochloride, USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each capsule, for oral administration contains 167 mg or 335 mg of ranitidine hydrochloride, USP equivalent to 150 mg and 300 mg of ranitidine, respectively. Inactive ingredients: ammonium hydroxide, colloidal silicon dioxide, corn starch, FD &amp; C Blue #1, FD &amp; C Red #40, FD &amp; C Yellow #6, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, simethicone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-3312-75</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00781-3312-75</NDC11Code>
    <ProductNDC>0781-3312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202521</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180323</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Palonosetron injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
    <Description>Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron HCl injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron equivalent to 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. The pH of the solution in the 5 mL vial is 4.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-3312-95</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-95)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00781-3312-95</NDC11Code>
    <ProductNDC>0781-3312</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202521</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Palonosetron injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
    <Description>Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron HCl injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron equivalent to 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. The pH of the solution in the 5 mL vial is 4.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-3415-75</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00781-3415-75</NDC11Code>
    <ProductNDC>0781-3415</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180323</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202521</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181126</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Palonosetron injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
    <Description>Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron HCl injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron equivalent to 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. The pH of the solution in the 5 mL vial is 4.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>0781-3415-95</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-95)  / 5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>00781-3415-95</NDC11Code>
    <ProductNDC>0781-3415</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Palonosetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Palonosetron Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180323</StartMarketingDate>
    <EndMarketingDate>20260830</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202521</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241001</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260830</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Palonosetron injection is indicated in adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)., 2 acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC)., 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.</IndicationAndUsage>
    <Description>Palonosetron hydrochloride is an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[de]isoquinoline hydrochloride. The molecular formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron HCl injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron HCl injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron equivalent to 0.28 mg palonosetron hydrochloride, 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. The pH of the solution in the 5 mL vial is 4.5 to 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>67046-0781-3</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (67046-0781-3) </PackageDescription>
    <NDC11Code>67046-0781-03</NDC11Code>
    <ProductNDC>67046-0781</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prazosin Hydrochloride</ProprietaryName>
    <NonProprietaryName>Prazosin Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210971</ApplicationNumber>
    <LabelerName>Coupler LLC</LabelerName>
    <SubstanceName>PRAZOSIN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prazosin Hydrochloride Capsules, USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. 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. Prazosin Hydrochloride Capsules, USP can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
    <Description>Prazosin hydrochloride, USP a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: Molecular formula C 19H 21N 5O 4HCl. It is a white to tan powder, slightly soluble in water, practically insoluble in chloroform and acetone and has a molecular weight of 419.87. Each capsule, for oral administration, contains prazosin hydrochloride, USP equivalent (as the polyhydrate) to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: colloidal silicon dioxide, lactose monohydrate, lactose anhydrous, magnesium stearate and microcrystalline cellulose. The empty hard gelatin capsules contain black iron oxide, gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In addition, the 1 mg empty gelatin capsules contain D&amp;C Yellow No. 10 and FD&amp;C Green No. 3; the 2 mg empty gelatin capsules contain D&amp;C Red No. 28, D&amp;C Yellow No. 10, FD&amp;C Blue No. 1 and FD&amp;C Red No. 40; and the 5 mg empty gelatin capsules contain FD&amp;C Blue No. 1. The capsules shells are imprinted in edible ink which contains concentrated ammonium solution, potassium hydroxide, propylene glycol, shellac and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>0904-6355-61</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6355-61)</PackageDescription>
    <NDC11Code>00904-6355-61</NDC11Code>
    <ProductNDC>0904-6355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Donepezil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Donepezil Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110531</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201001</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DONEPEZIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-04-05</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>50090-6355-0</NDCCode>
    <PackageDescription>75 mL in 1 BOTTLE (50090-6355-0) </PackageDescription>
    <NDC11Code>50090-6355-00</NDC11Code>
    <ProductNDC>50090-6355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061228</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065334</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole. Amoxicillin for oral suspension, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin for oral suspension, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension and other antibacterial drugs, amoxicillin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by 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>Amoxicillin for oral suspension, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 200 mg or 400 mg anhydrous amoxicillin. Each 5 mL of the 200 mg and 400 mg reconstituted suspension contains 0.16 mEq (3.61 mg) of sodium; Inactive ingredients: sucrose, sodium citrate, sodium benzoate, edetate disodium, FD&amp;C Red No. 3, xanthan gum, bubble-gum flavor, and colloidal silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>54868-6355-0</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (54868-6355-0)  &gt; 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>54868-6355-00</NDC11Code>
    <ProductNDC>54868-6355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pred Mild</ProprietaryName>
    <NonProprietaryName>Prednisolone Acetate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20121101</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA017100</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>PREDNISOLONE ACETATE</SubstanceName>
    <StrengthNumber>1.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>PRED MILD® is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns).</IndicationAndUsage>
    <Description>PRED MILD® (prednisolone acetate ophthalmic suspension, USP) 0.12% is a topical anti-inflammatory agent for ophthalmic use. Structural Formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>63629-6355-1</NDCCode>
    <PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-6355-1) </PackageDescription>
    <NDC11Code>63629-6355-01</NDC11Code>
    <ProductNDC>63629-6355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxybutynin Chloride</ProprietaryName>
    <NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
    <DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070511</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076745</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150917</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>66715-6355-3</NDCCode>
    <PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (66715-6355-3) </PackageDescription>
    <NDC11Code>66715-6355-03</NDC11Code>
    <ProductNDC>66715-6355</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Extra Strength Antacid Tablets, Caseys 4good</ProprietaryName>
    <NonProprietaryName>Calcium Carbonate 750 Mg</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230801</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M001</ApplicationNumber>
    <LabelerName>Lil' Drug Store Prodsucts, Inc.</LabelerName>
    <SubstanceName>CALCIUM CARBONATE</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses relieves:. : 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0121-0781-04</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0121-0781-04)  / 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>00121-0781-04</NDC11Code>
    <ProductNDC>0121-0781</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Childrens Pain And Fever</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220928</StartMarketingDate>
    <EndMarketingDate>20240831</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20220928</StartMarketingDatePackage>
    <EndMarketingDatePackage>20240831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to: the common coldfluheadachesore throattoothache.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0173-0781-00</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0173-0781-00) </PackageDescription>
    <NDC11Code>00173-0781-00</NDC11Code>
    <ProductNDC>0173-0781</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lamictal</ProprietaryName>
    <ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
    <NonProprietaryName>Lamotrigine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110815</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022115</ApplicationNumber>
    <LabelerName>GlaxoSmithKline LLC</LabelerName>
    <SubstanceName>LAMOTRIGINE</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LAMICTAL XR is indicated for: 1 adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. (1.1), 2 conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). (1.2).</IndicationAndUsage>
    <Description>LAMICTAL XR (lamotrigine), an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is. LAMICTAL XR extended-release tablets are supplied for oral administration as 25-mg (yellow with white center), 50-mg (green with white center), 100-mg (orange with white center), 200-mg (blue with white center), 250-mg (purple with white center), and 300-mg (gray with white center) tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: glycerol monostearate, hypromellose, lactose monohydrate; magnesium stearate; methacrylic acid copolymer dispersion, polyethylene glycol 400, polysorbate 80, silicon dioxide (25- and 50-mg tablets only), titanium dioxide, triethyl citrate, carmine (250-mg tablet only), iron oxide black (50-, 250-, and 300-mg tablets only), iron oxide yellow (25-, 50-, and 100-mg tablets only), iron oxide red (100-mg tablet only), FD&amp;C Blue No. 2 Aluminum Lake (200- and 250-mg tablets only). Tablets are printed with edible black ink. LAMICTAL XR extended-release tablets contain a modified-release eroding formulation as the core. The tablets are coated with a clear enteric coat and have an aperture drilled through the coats on both faces of the tablet (DiffCORE) to enable a controlled release of drug in the acidic environment of the stomach. The combination of this and the modified-release core are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-0781-05</NDCCode>
    <PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-05) </PackageDescription>
    <NDC11Code>00378-0781-05</NDC11Code>
    <ProductNDC>0378-0781</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110825</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077081</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-06-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110825</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0378-0781-91</NDCCode>
    <PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0781-91) </PackageDescription>
    <NDC11Code>00378-0781-91</NDC11Code>
    <ProductNDC>0378-0781</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Fexofenadine</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110825</StartMarketingDate>
    <EndMarketingDate>20220228</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077081</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>60</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110825</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
</NDCList>