RESTful Lookup — Test-Drive (2007 – 2026)

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>59088-413-36</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (59088-413-36)  / 1 BOTTLE in 1 KIT (59088-413-14)  / 118 mL in 1 BOTTLE (59088-413-08) </PackageDescription>
    <NDC11Code>59088-0413-36</NDC11Code>
    <ProductNDC>59088-413</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-730-00</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (59088-730-00)  *  1 TUBE in 1 CARTON (45802-055-36)  / 80 g in 1 TUBE</PackageDescription>
    <NDC11Code>59088-0730-00</NDC11Code>
    <ProductNDC>59088-730</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Triasil</ProprietaryName>
    <NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20230120</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-02-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
    <Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-. C 24H 31FO 6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.1% or 1 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-413-06</NDCCode>
    <PackageDescription>1 BOTTLE in 1 KIT (59088-413-06)  / 710 mL in 1 BOTTLE (59088-413-39) </PackageDescription>
    <NDC11Code>59088-0413-06</NDC11Code>
    <ProductNDC>59088-413</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-413-31</NDCCode>
    <PackageDescription>500 mL in 1 BOTTLE (59088-413-31) </PackageDescription>
    <NDC11Code>59088-0413-31</NDC11Code>
    <ProductNDC>59088-413</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200605</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M014</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>62</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200605</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55758-413-36</NDCCode>
    <PackageDescription>36 POUCH in 1 CARTON (55758-413-36)  / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
    <NDC11Code>55758-0413-36</NDC11Code>
    <ProductNDC>55758-413</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Tabcin</ProprietaryName>
    <ProprietaryNameSuffix>Flu</ProprietaryNameSuffix>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M013</ApplicationNumber>
    <LabelerName>Pharmadel LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>325; 10; 5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240630</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of symptoms due to the common cold/ flu: 1 nasal congestion, 2 minor aches and pain, 3 headache, 4 and temporarily reduces fever.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63323-413-36</NDCCode>
    <PackageDescription>10 VIAL, MULTI-DOSE in 1 TRAY (63323-413-36)  / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>63323-0413-36</NDC11Code>
    <ProductNDC>63323-413</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neostigmine Methylsulfate</ProprietaryName>
    <NonProprietaryName>Neostigmine Methylsulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20150108</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA203629</ApplicationNumber>
    <LabelerName>Fresenius Kabi USA, LLC</LabelerName>
    <SubstanceName>NEOSTIGMINE METHYLSULFATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150108</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.</IndicationAndUsage>
    <Description>Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, has an empirical formula of C 13H 22N 2O 6S, a molecular weight of 334.39 g/mol and the following structural formula:. Neostigmine Methylsulfate Injection is formulated with neostigmine methylsulfate, a white crystalline powder, chemically designated as (m-hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate.   Neostigmine Methylsulfate Injection is available in two dosage strengths; 0.5 mg/mL, and 1 mg/mL in 10 mL multiple dose amber glass vials. The composition per mL is as follows.  Phenol is added as a preservative.  Acetic acid and/or sodium hydroxide may have been added for pH adjustment.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-083-00</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (59088-083-00)  *  9 BLISTER PACK in 1 CARTON (55111-292-09)  / 9 TABLET in 1 BLISTER PACK *  85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) </PackageDescription>
    <NDC11Code>59088-0083-00</NDC11Code>
    <ProductNDC>59088-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Migranow</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate, Camphor, Menthol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160418</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160418</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
    <Description>Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-015-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-015-54) </PackageDescription>
    <NDC11Code>59088-0015-54</NDC11Code>
    <ProductNDC>59088-015</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flotrex</ProprietaryName>
    <NonProprietaryName>Multivitamins, Sodium Fluoride 0.5 Mg</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250221</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>.5; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
    <StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
    <Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 0.5 mg. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.5 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&amp;C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-017-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-017-54) </PackageDescription>
    <NDC11Code>59088-0017-54</NDC11Code>
    <ProductNDC>59088-017</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flotrex</ProprietaryName>
    <NonProprietaryName>Multivitamins, Sodium Fluoride 0.25 Mg</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250319</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>.25; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
    <StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250319</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
    <Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid) ...................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ................................................................... 0.25 mg. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 0.25 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&amp;C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-018-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-018-54) </PackageDescription>
    <NDC11Code>59088-0018-54</NDC11Code>
    <ProductNDC>59088-018</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multivitamin</ProprietaryName>
    <NonProprietaryName>Multivitamin</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250515</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
    <StrengthNumber>750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5</StrengthNumber>
    <StrengthUnit>ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250515</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.</IndicationAndUsage>
    <Description>Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE. Vitamin C (as Sodium Ascorbate and Ascorbic Acid).............. 60 mg. Vitamin D3 (as Cholecalciferol)............................................ 10 mcg. Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg. Thiamin (as Thiamine Mononitrate).................................... 1.05 mg. Riboflavin............................................................................... 1.2 mg. Niacin (as Niacinamide)....................................................... 13.5 mg. Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg. Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE. (1000 mcg as L-5-Methylfolate). Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-020-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-020-54) </PackageDescription>
    <NDC11Code>59088-0020-54</NDC11Code>
    <ProductNDC>59088-020</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Flotrex</ProprietaryName>
    <NonProprietaryName>Multivitamins, Sodium Fluoride 1 Mg</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250710</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>1; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 300; 4.5</StrengthNumber>
    <StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>This prescription chewable tablet is indicated for the prevention and treatment of vitamin and fluoride deficiencies in patients at high risk for dental caries and inadequate dietary intake of essential vitamins. It is specifically formulated to support normal growth and development, promote bone and dental health, and aid in the maintenance of overall metabolic and immune function.</IndicationAndUsage>
    <Description>Active Ingredients:. Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate) ........................................................... 750 mcg RAE Vitamin C (as Ascorbic Acid: 24 mg, Sodium Ascorbate: 36 mg) ................. 60 mg Vitamin D3 (as Cholecalciferol) .................................................... 10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) .............................................. 6.75 mg Thiamin (as Thiamine Mononitrate) ........................................................... 1.05 mg Riboflavin (as Vitamin B2) ........................................................................... 1.2 mg Niacin (as Niacinamide) ............................................................................ 13.5 mg Vitamin B6 (as Pyridoxine HCl) ................................................................. 1.05 mg Folate (as Folic Acid)....................................... 510 mcg DFE (300 mcg Folic Acid) Vitamin B12 (as Cyanocobalamin) ............................................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................................... 1 mg. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Flotrex Multivitamin Chewable plus 1 mg Fluoride Tablets provide fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Stearic Acid (Vegetable), Sucrose, CI 42090 (FD&amp;C Blue No. 1 Aluminum Lake), CI 45410 (Red 27 Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-107-59</NDCCode>
    <PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-107-59) </PackageDescription>
    <NDC11Code>59088-0107-59</NDC11Code>
    <ProductNDC>59088-107</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110601</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A</SubstanceName>
    <StrengthNumber>10; 24; 10; 4.5; 300; 13.5; 1.05; 1.2; 36; .25; 1.05; 750</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59088-108-59</NDCCode>
    <PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-108-59) </PackageDescription>
    <NDC11Code>59088-0108-59</NDC11Code>
    <ProductNDC>59088-108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110601</StartMarketingDate>
    <EndMarketingDate>20250131</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A</SubstanceName>
    <StrengthNumber>10; 24; 10; 4.5; 300; 13.5; 1.05; 1.2; 36; .5; 1.05; 750</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250131</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>59088-109-59</NDCCode>
    <PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-109-59) </PackageDescription>
    <NDC11Code>59088-0109-59</NDC11Code>
    <ProductNDC>59088-109</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Multivitamin With Fluoride</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110601</StartMarketingDate>
    <EndMarketingDate>20250228</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SODIUM ASCORBATE; SODIUM FLUORIDE; THIAMINE MONONITRATE; VITAMIN A</SubstanceName>
    <StrengthNumber>10; 24; 10; 4.5; 300; 13.5; 1.05; 1.2; 36; 1; 1.05; 750</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-02-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20110601</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplements. Multivitamin with 1.0 mg Fluoride Chewable Tabletsprovide 1.0 mg fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm. Multivitamin with 1.0 mg Fluoride Chewable Tabletssupply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B 6, vitamin B 12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Multivitamin with 1.0 mg Fluoride Chewable Tabletsregularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tabletsis a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.</IndicationAndUsage>
    <Description>Other Ingredients:Aspartame, Croscarmellose Sodium, Grape Flavor, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Stearic Acid (vegetable source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&amp;C Blue No. 1 Aluminum Lake).</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-158-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-158-54) </PackageDescription>
    <NDC11Code>59088-0158-54</NDC11Code>
    <ProductNDC>59088-158</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Davimet-m</ProprietaryName>
    <NonProprietaryName>Multivitamin</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231130</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
    <StrengthNumber>750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1000; 4.5</StrengthNumber>
    <StrengthUnit>ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231130</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Davimet-M Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.</IndicationAndUsage>
    <Description>Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE Vitamin C (as Sodium Ascorbate &amp; Ascorbic Acid).............. 60 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 10 mg Thiamin (as Thiamine Mononitrate).................................... 1.05 mg Riboflavin............................................................................... 1.2 mg Niacin (as Niacinamide)....................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-160-54</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-160-54) </PackageDescription>
    <NDC11Code>59088-0160-54</NDC11Code>
    <ProductNDC>59088-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Davimet With Iron</ProprietaryName>
    <NonProprietaryName>Iron, Folate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240603</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; CHOLECALCIFEROL; IRON; RIBOFLAVIN; METHYLCOBALAMIN; SODIUM ASCORBATE; LEVOMEFOLATE CALCIUM; .ALPHA.-TOCOPHEROL ACETATE, DL-</SubstanceName>
    <StrengthNumber>750; 24; 13.5; 1.05; 1.05; 10; 11; 1.2; 4.5; 36; 1000; 6.75</StrengthNumber>
    <StrengthUnit>ug/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-11-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Davimet with Iron Multivitamin Chewable Tablets are indicated for the treatment of iron deficiency anemia and folate deficiency, commonly seen in conditionssuch as extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. They are also indicated for condition in which irondeficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as casesof metabolic stress, and in convalescence.</IndicationAndUsage>
    <Description>Each caplet contains: Vitamin A (as Retinyl Acetate).......................................750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)........ 60 mg Vitamin D3 (as Cholecalciferol)................................. 10 mcg (400 IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)........................ 6.75 mg Thiamin (as Thiamine Mononitrate)....................................... 1.05 mg Riboflavin................................................................................. 1.2 mg Niacin (as Niacinamide).......................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................. 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................................... 4.5 mcg Iron (as Iron Amino Acid Chelate)............................................... 11 mg. Other Ingredients: Aspartame, CI 15985 / [Yellow 6 Lake], Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural OrangeFlavor, Stearic Acid (Vegetable Source), Sucrose. Phenylketonurics: Phenylalanine 3.0 mg Per Tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-170-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-170-54) </PackageDescription>
    <NDC11Code>59088-0170-54</NDC11Code>
    <ProductNDC>59088-170</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Davimet With Fluoride</ProprietaryName>
    <NonProprietaryName>Multivitamin, Fluoride</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240228</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>SODIUM FLUORIDE; VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN</SubstanceName>
    <StrengthNumber>.75; 750; 24; 36; 10; 6.75; 1.05; 1.2; 13.5; 1.05; 1000; 4.5</StrengthNumber>
    <StrengthUnit>mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Folate Analog [EPC], Folic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Supplementation of the diet with ten essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Davimet with Flouride 0.75 mg Chewable Multivitamin provide 0.75 mg fluoride in tablet form for children 6-16 years of age in areas where the drinking water fluoride level is less than 0.3 ppm. Davimet with Flouride 0.75 mg Chewable Multivitamin supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. Children using Davimet with Flouride 0.75 mg Chewable Multivitamin regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Davimet with Flouride 0.75 mg Chewable Multivitamin is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.</IndicationAndUsage>
    <Description>Each Chewable Tablet Contains: Vitamin A (as Retinyl Acetate)............................................. 750 mcg RAE Vitamin C (as Sodium Ascorbate 36 mg and Ascorbic Acid 24 mg)............... 60 mg Vitamin D3 (as Cholecalciferol)......................................... 10 mcg (400IU) Vitamin E (as DL-Alpha Tocopheryl Acetate)............................... 6.75 mg Thiamin (as Thiamine Mononitrate)............................................. 1.05 mg Riboflavin...................................................................................... 1.2 mg Niacin (as Niacinamide)............................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride)................................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)........…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin).............................................. 4.5 mcg Fluoride (as Sodium Fluoride) ..................................................... 0.75 mg. Davimet with Flouride 0.75 mg Chewable Multivitamin active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Davimet with Flouride 0.75 mg Chewable Multivitamin provide sodium fluoride and ten essential vitamins in a chewable tablet. Other Ingredients: Aspartame, Croscarmellose Sodium, Natural Grape Flavor, Magnesium Stearate (Vegetable Source), Maltodextrin, Microcrystalline Cellulose, Stearic Acid (Vegetable Source), Sucrose, CI 45410 (Red 27 Lake), CI 42090 (FD&amp;C Blue No. 1 Aluminum Lake). Phenylketonurics: Contains Phenylalanine 3.0 mg Per Tablet.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-695-54</NDCCode>
    <PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (59088-695-54) </PackageDescription>
    <NDC11Code>59088-0695-54</NDC11Code>
    <ProductNDC>59088-695</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Davimet</ProprietaryName>
    <NonProprietaryName>Multivitamin</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220919</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>VITAMIN A; ASCORBIC ACID; SODIUM ASCORBATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; PYRIDOXINE HYDROCHLORIDE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; FOLIC ACID; CYANOCOBALAMIN</SubstanceName>
    <StrengthNumber>750; 24; 36; 10; 10; 1.05; 1.05; 1.2; 13.5; 1667; 4.5</StrengthNumber>
    <StrengthUnit>ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Davimet Multivitamin Chewable Tablets is indicated to provide significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Expressly formulated to provide essential nutrients, tailored to the needs of all individuals ages 4 years old and above, promoting overall health, energy, and vitality.</IndicationAndUsage>
    <Description>Each Chewable Tablet Contains. Vitamin A (as Retinyl Acetate).................................... 750 mcg RAE Vitamin C (as Sodium Ascorbate &amp; Ascorbic Acid).............. 60 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)....................... 10 mg Thiamin (as Thiamine Mononitrate).................................... 1.05 mg Riboflavin............................................................................... 1.2 mg Niacin (as Niacinamide)....................................................... 13.5 mg Vitamin B6 (as Pyridoxine Hydrochloride).......................... 1.05 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)..................................... 4.5 mcg.</Description>
  </NDC>
  <NDC>
    <NDCCode>35356-439-36</NDCCode>
    <PackageDescription>36 TABLET in 1 BOTTLE (35356-439-36) </PackageDescription>
    <NDC11Code>35356-0439-36</NDC11Code>
    <ProductNDC>35356-439</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan Succinate</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091117</StartMarketingDate>
    <EndMarketingDate>20251031</EndMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076847</ApplicationNumber>
    <LabelerName>Quality Care Products, LLC</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20221108</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <Description>Sumatriptan tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 receptor subtype agonist. Sumatriptan succinate is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-291-36</NDCCode>
    <PackageDescription>36 TABLET in 1 BOTTLE (55111-291-36) </PackageDescription>
    <NDC11Code>55111-0291-36</NDC11Code>
    <ProductNDC>55111-291</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan Succinate</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076847</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:.  Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks.  Sumatriptan tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder that is freely soluble in water, sparingly soluble in methanol, practically inso. luble in methylene chloride. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-292-36</NDCCode>
    <PackageDescription>36 TABLET in 1 BOTTLE (55111-292-36) </PackageDescription>
    <NDC11Code>55111-0292-36</NDC11Code>
    <ProductNDC>55111-292</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan Succinate</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076847</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:.  Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks.  Sumatriptan tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder that is freely soluble in water, sparingly soluble in methanol, practically inso. luble in methylene chloride. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>55111-293-36</NDCCode>
    <PackageDescription>36 TABLET in 1 BOTTLE (55111-293-36) </PackageDescription>
    <NDC11Code>55111-0293-36</NDC11Code>
    <ProductNDC>55111-293</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan Succinate</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091117</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076847</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091117</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use:.  Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks.  Sumatriptan tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder that is freely soluble in water, sparingly soluble in methanol, practically inso. luble in methylene chloride. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>55513-413-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (55513-413-01)  / .2 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>55513-0413-01</NDC11Code>
    <ProductNDC>55513-413</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amjevita</ProprietaryName>
    <NonProprietaryName>Adalimumab-atto</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20230406</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761024</ApplicationNumber>
    <LabelerName>Amgen, Inc</LabelerName>
    <SubstanceName>ADALIMUMAB</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.2mL</StrengthUnit>
    <Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230406</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: : 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
    <Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with glacial acetic acid (0.48 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (72 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with glacial acetic acid (0.24 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (36 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with glacial acetic acid (0.12 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (18 mg), and Water for Injection, USP, pH 5.2.</Description>
  </NDC>
  <NDC>
    <NDCCode>64980-660-36</NDCCode>
    <PackageDescription>36 TABLET, FILM COATED in 1 BOTTLE (64980-660-36) </PackageDescription>
    <NDC11Code>64980-0660-36</NDC11Code>
    <ProductNDC>64980-660</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219036</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan 25 mg, 50 mg and 100 mg tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a White or almost white powder that is readily soluble in water and in saline. Each Sumatriptan tablets, USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 25-mg and 50-mg tablet also contains hypromellose, titanium dioxide and triacetin. Each 100-mg tablet also contains hypromellose, iron oxide red, titanium dioxide, and triacetin. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>64980-661-36</NDCCode>
    <PackageDescription>36 TABLET, FILM COATED in 1 BOTTLE (64980-661-36) </PackageDescription>
    <NDC11Code>64980-0661-36</NDC11Code>
    <ProductNDC>64980-661</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219036</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan 25 mg, 50 mg and 100 mg tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a White or almost white powder that is readily soluble in water and in saline. Each Sumatriptan tablets, USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 25-mg and 50-mg tablet also contains hypromellose, titanium dioxide and triacetin. Each 100-mg tablet also contains hypromellose, iron oxide red, titanium dioxide, and triacetin. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>64980-662-36</NDCCode>
    <PackageDescription>36 TABLET, FILM COATED in 1 BOTTLE (64980-662-36) </PackageDescription>
    <NDC11Code>64980-0662-36</NDC11Code>
    <ProductNDC>64980-662</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250505</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA219036</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250723</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan 25 mg, 50 mg and 100 mg tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks., 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a White or almost white powder that is readily soluble in water and in saline. Each Sumatriptan tablets, USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 25-mg and 50-mg tablet also contains hypromellose, titanium dioxide and triacetin. Each 100-mg tablet also contains hypromellose, iron oxide red, titanium dioxide, and triacetin. FDA approved dissolution test specifications differ from USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-146-36</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (65862-146-36)  / 9 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>65862-0146-36</NDC11Code>
    <ProductNDC>65862-146</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-146-59</NDCCode>
    <PackageDescription>36 TABLET in 1 BOTTLE (65862-146-59) </PackageDescription>
    <NDC11Code>65862-0146-59</NDC11Code>
    <ProductNDC>65862-146</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-147-36</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (65862-147-36)  / 9 TABLET in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>65862-0147-36</NDC11Code>
    <ProductNDC>65862-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090817</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
  </NDC>
  <NDC>
    <NDCCode>65862-147-59</NDCCode>
    <PackageDescription>36 TABLET in 1 BOTTLE (65862-147-59) </PackageDescription>
    <NDC11Code>65862-0147-59</NDC11Code>
    <ProductNDC>65862-147</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sumatriptan</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090817</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078327</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220622</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. , 2 Sumatriptan tablets are not indicated for the prevention of migraine attacks. , 3 Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. .</IndicationAndUsage>
    <Description>Sumatriptan tablets, USP contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole­-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet, USP for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.</Description>
  </NDC>
</NDCList>