RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>50090-0828-0</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-0) </PackageDescription>
    <NDC11Code>50090-0828-00</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>52946-0828-0</NDCCode>
    <PackageDescription>20 kg in 1 BOX (52946-0828-0)</PackageDescription>
    <NDC11Code>52946-0828-00</NDC11Code>
    <ProductNDC>52946-0828</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Cefoxitin Sodium</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20091209</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>ACS Dobfar S.p.A</LabelerName>
    <SubstanceName>CEFOXITIN SODIUM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2019-12-21</LastUpdate>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>60905-0828-0</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, GLASS (60905-0828-0) </PackageDescription>
    <NDC11Code>60905-0828-00</NDC11Code>
    <ProductNDC>60905-0828</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Teint Couture Everwear 24h Wear Satin Finish Full Coverage And Comfort Broad Spectrum Spf 20 N365</ProprietaryName>
    <NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>LVMH FRAGRANCE BRANDS</LabelerName>
    <SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>30; 17.5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61398-0828-0</NDCCode>
    <PackageDescription>3455 L in 1 CYLINDER (61398-0828-0) </PackageDescription>
    <NDC11Code>61398-0828-00</NDC11Code>
    <ProductNDC>61398-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Oxygen</ProprietaryName>
    <NonProprietaryName>Oxygen</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20091202</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
    <LabelerName>Complete Care Inc</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>99</StrengthNumber>
    <StrengthUnit>L/100L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>70518-0828-0</NDCCode>
    <PackageDescription>6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (70518-0828-0) </PackageDescription>
    <NDC11Code>70518-0828-00</NDC11Code>
    <ProductNDC>70518-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron</ProprietaryName>
    <NonProprietaryName>Ondansetron</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171108</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078050</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>ONDANSETRON</SubstanceName>
    <StrengthNumber>8</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-05-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71335-0828-0</NDCCode>
    <PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (71335-0828-0) </PackageDescription>
    <NDC11Code>71335-0828-00</NDC11Code>
    <ProductNDC>71335-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Methocarbamol</ProprietaryName>
    <NonProprietaryName>Methocarbamol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180115</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208507</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>METHOCARBAMOL</SubstanceName>
    <StrengthNumber>750</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
    <Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&amp;C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&amp;C Yellow #10 Aluminum Lake, FD&amp;C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-2</NDCCode>
    <PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-2) </PackageDescription>
    <NDC11Code>50090-0828-02</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-3</NDCCode>
    <PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-3) </PackageDescription>
    <NDC11Code>50090-0828-03</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-4</NDCCode>
    <PackageDescription>20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-4) </PackageDescription>
    <NDC11Code>50090-0828-04</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-5</NDCCode>
    <PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-5) </PackageDescription>
    <NDC11Code>50090-0828-05</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-6</NDCCode>
    <PackageDescription>200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-6) </PackageDescription>
    <NDC11Code>50090-0828-06</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-7</NDCCode>
    <PackageDescription>180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-7) </PackageDescription>
    <NDC11Code>50090-0828-07</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-8</NDCCode>
    <PackageDescription>7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-8) </PackageDescription>
    <NDC11Code>50090-0828-08</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141128</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-0828-9</NDCCode>
    <PackageDescription>120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0828-9) </PackageDescription>
    <NDC11Code>50090-0828-09</NDC11Code>
    <ProductNDC>50090-0828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021104</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075410</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191010</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole Delayed-Release Capsules is a proton pump inhibitor (PPI) indicated for the: 1 Treatment of active duodenal ulcer in adults (1.1) , 2 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2) , 3 Treatment of active benign gastric ulcer in adults (1.3) , 4 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 1 year of age and older (1.4) , 5 Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 1 year of age and older (1.5) , 6 Maintenance of healing of EE due to acid-mediated GERD in patients 1 year of age and older (1.6) , 7 Pathologic hypersecretory conditions in adults (1.7) .</IndicationAndUsage>
    <Description>The active ingredient in Omeprazole Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole Delayed-Release Capsules meet USP Dissolution Test 2. Omeprazole Delayed-Release Capsules is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg, or 40 mg of omeprazole in the form of enteric-coated microtablets with the following inactive ingredients: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. In addition, the capsule shells contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>10922-828-06</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (10922-828-06)  &gt; 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>10922-0828-06</NDC11Code>
    <ProductNDC>10922-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonate</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100128</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021844</ApplicationNumber>
    <LabelerName>Intendis Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Desonate contains desonide [(pregna-1, 4-diene-3, 20-dione,11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-,(11β,16α)]- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C24H32O6. It has the following structural formula. Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonate contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium dihydrate, methylparaben, propylparaben, sodium hydroxide, and Carbopol® 981.</Description>
  </NDC>
  <NDC>
    <NDCCode>10922-828-12</NDCCode>
    <PackageDescription>2 TUBE in 1 CARTON (10922-828-12)  &gt; 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>10922-0828-12</NDC11Code>
    <ProductNDC>10922-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonate</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100128</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021844</ApplicationNumber>
    <LabelerName>Intendis Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Desonate contains desonide [(pregna-1, 4-diene-3, 20-dione,11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-,(11β,16α)]- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C24H32O6. It has the following structural formula. Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonate contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium dihydrate, methylparaben, propylparaben, sodium hydroxide, and Carbopol® 981.</Description>
  </NDC>
  <NDC>
    <NDCCode>10922-828-71</NDCCode>
    <PackageDescription>1 TUBE in 1 BLISTER PACK (10922-828-71)  &gt; 3.5 g in 1 TUBE</PackageDescription>
    <NDC11Code>10922-0828-71</NDC11Code>
    <ProductNDC>10922-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonate</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20100128</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021844</ApplicationNumber>
    <LabelerName>Intendis Inc.</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use Desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Desonate contains desonide [(pregna-1, 4-diene-3, 20-dione,11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-,(11β,16α)]- a synthetic nonfluorinated corticosteroid for topical dermatologic use. Chemically, desonide is C24H32O6. It has the following structural formula. Desonide has the molecular weight of 416.52. It is a white to off-white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonate contains 0.5 mg of desonide in an aqueous gel base of purified water, glycerin, propylene glycol, edetate disodium dihydrate, methylparaben, propylparaben, sodium hydroxide, and Carbopol® 981.</Description>
  </NDC>
  <NDC>
    <NDCCode>14537-828-35</NDCCode>
    <PackageDescription>24 BAG in 1 CARTON (14537-828-35)  / 350 mL in 1 BAG</PackageDescription>
    <NDC11Code>14537-0828-35</NDC11Code>
    <ProductNDC>14537-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Additive Formula 3</ProprietaryName>
    <NonProprietaryName>Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, And Adenine</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20020529</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN001214</ApplicationNumber>
    <LabelerName>Terumo BCT, Ltd</LabelerName>
    <SubstanceName>ADENINE; CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE</SubstanceName>
    <StrengthNumber>.03; .042; 1.1; .41; .28; .59</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20020529</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Use only with Trima Accel red blood cell (RBC) apheresis collections. [See Dosage and Administration (2).].</IndicationAndUsage>
    <Description>ADDITIVE SOLUTION FORMULA 3 (AS-3) is designed to be added to packed RBC collected in apheresis procedures, and acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The solution is intended to be metered by an apheresis device during apheresis procedures or added manually after a collection. The solution is sterile and non-pyrogenic, and it contains no bacteriostatic or antimicrobial agents. The formulas of the active ingredients are provided in Table 1. Each 100 mL of ADDITIVE SOLUTION FORMULA 3 (AS-3) contains: Dextrose Monohydrate USP 1.10 g; Trisodium Citrate Dihydrate USP 0.59 g; Sodium Chloride USP 0.41 g; Monobasic Sodium Phosphate Monohydrate USP 0.28 g; Citric Acid Monohydrate USP 0.042 g; Adenine USP 0.03 g; and Water for Injection USP. ADDITIVE SOLUTION FORMULA 3 is available in three volumes: 100 mL, 200 mL and 350 mL. The 100 mL bags are individually wrapped with a clear plastic film. Six individually wrapped bags are then vacuum-sealed in a foil pouch, which serves as a vapor barrier to prevent water loss during storage. After you remove the individual solution bags from the foil pouch, you can either leave them in the clear plastic film or remove and discard it. Once the foil pouch has been opened, use all six of the solution bags within 2 weeks. The 200 mL and 350 mL bags are individually wrapped with a clear plastic film. These larger volumes do not require the additional vapor barrier. Once the clear plastic film has been removed, use the solution within 2 weeks. The Polyolefin bag is not made with natural rubber latex. The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-828-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16714-828-01)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>16714-0828-01</NDC11Code>
    <ProductNDC>16714-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonide</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209996</ApplicationNumber>
    <LabelerName>Northstar Rx LLC</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180716</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desonide Ointment, 0.05% is a low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
    <Description>Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula:. The molecular weight of desonide is 416.51. It is a white powder and practically insoluble in water; sparingly soluble in ethanol and in acetone; soluble in chloroform. Each gram of Desonide Ointment, 0.05% contains 0.5 mg of desonide in an ointment base consisting of white petrolatum and mineral oil.</Description>
  </NDC>
  <NDC>
    <NDCCode>16714-828-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (16714-828-02)  / 60 g in 1 TUBE</PackageDescription>
    <NDC11Code>16714-0828-02</NDC11Code>
    <ProductNDC>16714-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Desonide</ProprietaryName>
    <NonProprietaryName>Desonide</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209996</ApplicationNumber>
    <LabelerName>Northstar Rx LLC</LabelerName>
    <SubstanceName>DESONIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180716</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Desonide Ointment, 0.05% is a low potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
    <Description>Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula:. The molecular weight of desonide is 416.51. It is a white powder and practically insoluble in water; sparingly soluble in ethanol and in acetone; soluble in chloroform. Each gram of Desonide Ointment, 0.05% contains 0.5 mg of desonide in an ointment base consisting of white petrolatum and mineral oil.</Description>
  </NDC>
  <NDC>
    <NDCCode>25021-828-50</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (25021-828-50)  / 50 mL in 1 VIAL</PackageDescription>
    <NDC11Code>25021-0828-50</NDC11Code>
    <ProductNDC>25021-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leucovorin Calcium</ProprietaryName>
    <NonProprietaryName>Leucovorin Calcium</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20180415</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209110</ApplicationNumber>
    <LabelerName>Sagent Pharmaceuticals</LabelerName>
    <SubstanceName>LEUCOVORIN CALCIUM</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/50mL</StrengthUnit>
    <Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Leucovorin rescue is indicated after high-dose methotrexate therapy in osteosarcoma. Leucovorin Calcium for Injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium for Injection is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium for Injection is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin Calcium for Injection should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.</IndicationAndUsage>
    <Description>Leucovorin is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to drugs which act as folic acid antagonists. Also known as folinic acid, Citrovorum factor, or 5-formyl-5,6,7,8-tetrahydrofolic acid, this compound has the chemical designation of Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1). The structural formula of leucovorin calcium is:. Leucovorin Calcium for Injection, USP is a sterile product indicated for intramuscular (IM) or intravenous (IV) administration and is supplied in 500 mg vials. Each 500 mg vial of Leucovorin Calcium for Injection, USP, when reconstituted with 50 mL of sterile diluent, contains leucovorin (as the calcium salt) 10 mg per mL. In this dosage form, one milligram of leucovorin calcium contains 0.002 mmol of leucovorin and 0.002 mmol of calcium. This lyophilized product contains no preservative. The inactive ingredient is sodium chloride added to adjust tonicity. Reconstitute with Bacteriostatic Water for Injection, USP, which contains benzyl alcohol (see WARNINGS), or with Sterile Water for Injection, USP. The inactive ingredient is sodium chloride 450 mg per vial for the 500 mg. Sodium hydroxide and/or hydrochloric acid may be added for pH adjustment. pH adjusted to approximately 7.8. There is 0.004 mEq of calcium per mg of leucovorin. Solution contains no bacteriostat or antimicrobial agents.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-828-26</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-828-26) </PackageDescription>
    <NDC11Code>51655-0828-26</NDC11Code>
    <ProductNDC>51655-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Losartan Potassium</ProprietaryName>
    <NonProprietaryName>Losartan Potassium</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220221</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203835</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Losartan Potassium tablets are an angiotensin II receptor blocker (ARB) indicated for:  Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1)  Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2)  Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3).</IndicationAndUsage>
    <Description>Losartan potassium is an angiotensin II receptor blocker acting on the AT 1receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt. Its molecular formula is C 22H 22ClKN 6O, and its structural formula is:. Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water and slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients: crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch. The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide. Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. The botanical source for pregelatinized starch is corn starch.</Description>
  </NDC>
  <NDC>
    <NDCCode>62135-828-84</NDCCode>
    <PackageDescription>6 POUCH in 1 CARTON (62135-828-84)  / 5 VIAL in 1 POUCH / 3 mL in 1 VIAL</PackageDescription>
    <NDC11Code>62135-0828-84</NDC11Code>
    <ProductNDC>62135-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Albuterol Sulfate</ProprietaryName>
    <NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19970917</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074880</ApplicationNumber>
    <LabelerName>Chartwell RX, LLC</LabelerName>
    <SubstanceName>ALBUTEROL SULFATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/3mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Albuterol sulfate inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
    <Description>Albuterol sulfate inhalation solution is a relatively selective beta 2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGYsection below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α 1-[( tert-Butylamino)methyl]-4-hydroxy- m-xylene-α,α′-diol sulfate (2:1) (salt) and the following structural formula:. Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C 13H 21NO 3) 2H 2SO 4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization’s recommended name for albuterol base is salbutamol. Albuterol sulfate inhalation solution 0.083% requires no dilution before administration. Each mL of albuterol sulfate inhalation solution (0.083%) contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol sulfate inhalation solution (0.083%) contains no sulfiting agents. Albuterol sulfate inhalation solution is a clear, colorless solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>65044-0828-5</NDCCode>
    <PackageDescription>5 mL in 1 VIAL (65044-0828-5) </PackageDescription>
    <NDC11Code>65044-0828-05</NDC11Code>
    <ProductNDC>65044-0828</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</ProprietaryName>
    <NonProprietaryName>Standardized Grass Pollen, Sweet Vernal Grass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL</RouteName>
    <StartMarketingDate>19980115</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103878</ApplicationNumber>
    <LabelerName>Jubilant HollisterStier LLC</LabelerName>
    <SubstanceName>ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>1000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19980115</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>16, 17, 18, 20. Standardized glycerinated allergenic extracts in potencies of 10,000 BAU/mL and 100,000 BAU/mL are indicated for use in diagnosis and immunotherapy of patients presenting symptoms of allergy (hay fever, rhinitis, etc.) to specific grass pollens. Concentrated extracts must be diluted prior to use in intradermal testing and immunotherapy. The selection of allergenic extracts to be used should be based on a thorough and carefully taken history of hypersensitivity, and confirmed by skin testing. 27, 28 10,000 BAU/mL dose form should be used initially for percutaneous testing. If negative, the 100,000 BAU/mL dose can be used. The use of mixed or unrelated antigens for skin testing is not recommended since, in the case of a positive reaction, it does not indicate which component of the mix is responsible for the reaction, while, in the case of a negative reaction, it fails to indicate whether the individual antigens at full concentration would give a positive reaction. Utilization of such mixes for compounding a treatment may result, in the former case, in administering unnecessary antigens and, in the latter case, in the omission of a needed allergen. Allergens to which a patient is extremely sensitive should not be included in treatment mixes with allergens to which there is much less sensitivity, but should be administered separately. This allows individualized and better control of dosage increases, including adjustments in dosage becoming necessary after severe reactions which may occur to the highly reactive allergen. Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products.</IndicationAndUsage>
    <Description>The grass pollens available in standardized form are: Bermuda Grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Perennial Ryegrass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky Bluegrass (Poa pratensis), Meadow Fescue (Festuca elatior), and Sweet Vernalgrass (Anthoxanthum odoratum). The pollen extracts are intended for subcutaneous injection for immunotherapy; and intradermal and prick or puncture for diagnosis. Pollen extracts are sterile solutions containing the extractables of pollens, 0.5% Sodium Chloride, 0.275% Sodium Bicarbonate, and 50% Glycerin by volume as a preservative. Sterile, diluted Standardized Grass Pollen Extracts available for intradermal testing contain 0.9% sodium chloride, not more than 0.5% glycerin by volume, 0.03% sodium bicarbonate, and 0.4% phenol as a preservative. Source material for the extracts is collected using techniques such as water set or vacuuming. Source material for allergenic extracts contains no more than a total of 1% of detectable foreign materials (99% pollen purity). Note: BAU/mL Standardized grass pollens are not interchangeable with any other grass pollen products. Product Concentration:1. Bioequivalent Allergy Units. These allergenic extracts are labeled in Bioequivalent Allergy Units/mL (BAU/mL) based on their comparison (by ELISA Competition) to Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Reference Preparations.2 The FDA reference extracts have been assigned Bioequivalent Allergy Units based on the CBER ID50EAL method.5 Briefly, highly sensitive patients are skin tested to the reference preparation using an intradermal technique employing 3-fold extract dilutions. Depending on the dilution which elicits a summation of erythema diameter of 50mm (D50), Bioequivalent Allergy Units are assigned as follows. The vial potency of Mixtures of Standardized Grasses is calculated by summation of the BAU/mL values of the components of the ingredient list which expresses the potency of each component per mL of the mixture. 2. Concentrate.a. Concentrate label terminology applies to allergenic extract Custom Mixtures where the individual allergens being combined vary in strength or the designation of strength. Should the physician choose to calculate the actual strength of each component in the "Concentrate" mixture, the following formulation may be used. b. In the list of components portion of the product label for Stock Mixtures Containing Standardized Grasses, the potency of each component is calculated to express the potency of each component per 1 mL of the mixture. Vial potency is expressed as concentrate, or as a volume/volume dilution of concentrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>68180-828-09</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68180-828-09) </PackageDescription>
    <NDC11Code>68180-0828-09</NDC11Code>
    <ProductNDC>68180-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fyavolv</ProprietaryName>
    <NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204213</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ETHINYL ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
    <StrengthNumber>.005; 1</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).</IndicationAndUsage>
    <Description>Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available. Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with "F51" on one side and "LU" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with "F52" on one side and "LU" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&amp;C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Molecular Weight: 296.40. Molecular Formula: C20H24O2. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. Molecular Weight: 340.46. Molecular Formula: C22H28O3.</Description>
  </NDC>
  <NDC>
    <NDCCode>68180-828-73</NDCCode>
    <PackageDescription>3 POUCH in 1 CARTON (68180-828-73)  / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>68180-0828-73</NDC11Code>
    <ProductNDC>68180-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fyavolv</ProprietaryName>
    <NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160315</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204213</ApplicationNumber>
    <LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ETHINYL ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
    <StrengthNumber>.005; 1</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fyavolv is a combination of an estrogen and progestin indicated in a woman with a uterus for: 1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause (1.1), 2 Prevention of Postmenopausal Osteoporosis (1.2).</IndicationAndUsage>
    <Description>Fyavolv (norethindrone acetate and ethinyl estradiol tablets USP) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following strength of Fyavolv tablets is available. Fyavolv (0.5 mg/0.0025 mg): Each white to off-white, round film-coated tablet, debossed with "F51" on one side and "LU" on the other side contains 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. Fyavolv (1 mg/0.005 mg): Each blue, round film-coated tablet, debossed with "F52" on one side and "LU" on the other side contains 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol. Each tablet contains the following inactive ingredients: calcium stearate, corn starch, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide and vitamin E. Each tablet of 1 mg/0.005 mg also contains FD&amp;C Blue No. 2 Aluminum Lake. The structural formulas are as follows. Ethinyl Estradiol [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. Molecular Weight: 296.40. Molecular Formula: C20H24O2. Norethindrone Acetate [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. Molecular Weight: 340.46. Molecular Formula: C22H28O3.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-828-10</NDCCode>
    <PackageDescription>10 TABLET in 1 BOTTLE (71610-828-10) </PackageDescription>
    <NDC11Code>71610-0828-10</NDC11Code>
    <ProductNDC>71610-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076045</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-828-15</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (71610-828-15) </PackageDescription>
    <NDC11Code>71610-0828-15</NDC11Code>
    <ProductNDC>71610-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076045</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240614</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-828-28</NDCCode>
    <PackageDescription>28 TABLET in 1 BOTTLE (71610-828-28) </PackageDescription>
    <NDC11Code>71610-0828-28</NDC11Code>
    <ProductNDC>71610-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076045</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
  <NDC>
    <NDCCode>71610-828-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (71610-828-30) </PackageDescription>
    <NDC11Code>71610-0828-30</NDC11Code>
    <ProductNDC>71610-828</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lorazepam</ProprietaryName>
    <NonProprietaryName>Lorazepam</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231026</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076045</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>LORAZEPAM</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2025-04-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240502</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
    <Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
  </NDC>
</NDCList>