RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>72189-126-18</NDCCode>
    <PackageDescription>18 TABLET in 1 BLISTER PACK (72189-126-18) </PackageDescription>
    <NDC11Code>72189-0126-18</NDC11Code>
    <ProductNDC>72189-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201111</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203252</ApplicationNumber>
    <LabelerName>direct rx</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>5</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>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20201111</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck &amp; Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck &amp; Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. Limitations of Use. Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablet is administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets contains rizatriptan benzoate USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. [Structure]. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate USP is a white to almost white, crystalline powder that is soluble in water and methanol, slightly soluble in isopropyl alcohol. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, ferric oxide (red), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>24979-126-18</NDCCode>
    <PackageDescription>60 VIAL, SINGLE-USE in 1 CARTON (24979-126-18)  / .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>24979-0126-18</NDC11Code>
    <ProductNDC>24979-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cyclosporine</ProprietaryName>
    <NonProprietaryName>Cyclosporine</NonProprietaryName>
    <DosageFormName>EMULSION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20260327</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209064</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>CYCLOSPORINE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260327</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Cyclosporine ophthalmic emulsion 0.05% is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.</IndicationAndUsage>
    <Description>Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure. Structural Formula. Formula: C62H111N11O12 Mol. Wt.: 1202.6. Cyclosporine is a fine white powder. Cyclosporine ophthalmic emulsion 0.05% appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of cyclosporine ophthalmic emulsion 0.05% contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>52959-126-18</NDCCode>
    <PackageDescription>18 TABLET in 1 BOTTLE, PLASTIC (52959-126-18)</PackageDescription>
    <NDC11Code>52959-0126-18</NDC11Code>
    <ProductNDC>52959-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20020712</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA040256</ApplicationNumber>
    <LabelerName>H.J. Harkins Company, Inc.</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>PredniSONE Tablets are indicated in the following conditions: 1 Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance)Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer, 2 Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis, 3 Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis, 4 Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis, 5 Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions, 6 Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis, 7 Respiratory DiseasesSymptomatic sarcoidosisLoeffler's syndrome not manageable by other meansBerylliosisAspiration pneumonitisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, 8 Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia, 9 Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood, 10 Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus, 11 Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis, 12 MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below. PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.</Description>
  </NDC>
  <NDC>
    <NDCCode>53157-126-62</NDCCode>
    <PackageDescription>18 POUCH in 1 BOX (53157-126-62)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG</PackageDescription>
    <NDC11Code>53157-0126-62</NDC11Code>
    <ProductNDC>53157-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leukotrap Wb System - Cp2d</ProprietaryName>
    <NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151007</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN820915</ApplicationNumber>
    <LabelerName>Haemonetics Manufacturing Inc</LabelerName>
    <SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>3.57</StrengthNumber>
    <StrengthUnit>g/70mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.</IndicationAndUsage>
    <Description>CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>53157-126-63</NDCCode>
    <PackageDescription>18 POUCH in 1 BOX (53157-126-63)  / 3 BAG in 1 POUCH / 70 mL in 1 BAG</PackageDescription>
    <NDC11Code>53157-0126-63</NDC11Code>
    <ProductNDC>53157-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Leukotrap Wb System - Cp2d</ProprietaryName>
    <NonProprietaryName>Cp2d/as-3 Anticoagulant And Additive System</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151007</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN820915</ApplicationNumber>
    <LabelerName>Haemonetics Manufacturing Inc</LabelerName>
    <SubstanceName>DEXTROSE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>3.57</StrengthNumber>
    <StrengthUnit>g/70mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151007</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.</IndicationAndUsage>
    <Description>CP2D/AS-3 Blood Bag Unit with In-Line WBF Filter and Sampling System. Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>57664-126-18</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (57664-126-18) </PackageDescription>
    <NDC11Code>57664-0126-18</NDC11Code>
    <ProductNDC>57664-126</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
    <NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090330</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA090118</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>5; 325</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
    <DEASchedule>CII</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2020-08-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69842-126-18</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69842-126-18)  &gt; 18 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>69842-0126-18</NDC11Code>
    <ProductNDC>69842-126</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Chocolate Flavored Senna</ProprietaryName>
    <NonProprietaryName>Standardized Senna Concentrate</NonProprietaryName>
    <DosageFormName>TABLET, CHEWABLE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150821</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>CVS Pharmacy,Inc.</LabelerName>
    <SubstanceName>SENNOSIDES</SubstanceName>
    <StrengthNumber>8.6</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: 1 relieves occasional constipation (irregularity), 2 generally produces a bowel movement in 6-12 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>72189-181-18</NDCCode>
    <PackageDescription>18 LOZENGE in 1 CARTON (72189-181-18) </PackageDescription>
    <NDC11Code>72189-0181-18</NDC11Code>
    <ProductNDC>72189-181</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sore Throat Logenzes Sore Throat-</ProprietaryName>
    <NonProprietaryName>Benzocaine And Menthol</NonProprietaryName>
    <DosageFormName>LOZENGE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210223</StartMarketingDate>
    <EndMarketingDate>20230831</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part356</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>BENZOCAINE; MENTHOL</SubstanceName>
    <StrengthNumber>15; 3.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20210223</StartMarketingDatePackage>
    <EndMarketingDatePackage>20230831</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>72189-258-18</NDCCode>
    <PackageDescription>18 TABLET in 1 BLISTER PACK (72189-258-18) </PackageDescription>
    <NDC11Code>72189-0258-18</NDC11Code>
    <ProductNDC>72189-258</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210810</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202490</ApplicationNumber>
    <LabelerName>direct rx</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>10</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>2026-03-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210810</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Information related to usage of rizatriptan benzoate in pediatric patients (6 to 17 years old) is approved for Merck &amp; Co., Inc.’s Rizatriptan Benzoate Tablets. However, due to Merck &amp; Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric patient (6 to 17 years old) usage information. Limitations of Use. Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablet is administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets contains rizatriptan benzoate USP, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. [Structure]. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate USP is a white to almost white, crystalline powder that is soluble in water and methanol, slightly soluble in isopropyl alcohol. Rizatriptan benzoate tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, ferric oxide (red), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-316-18</NDCCode>
    <PackageDescription>18 TABLET in 1 BOTTLE (72189-316-18) </PackageDescription>
    <NDC11Code>72189-0316-18</NDC11Code>
    <ProductNDC>72189-316</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203269</ApplicationNumber>
    <LabelerName>Direct Rx</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>5</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>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use. Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablet, USP contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is:. [rizatriptan-Structure]. Its empirical formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate Tablets, USP are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-447-18</NDCCode>
    <PackageDescription>18 TABLET, FILM COATED in 1 CARTON (72189-447-18) </PackageDescription>
    <NDC11Code>72189-0447-18</NDC11Code>
    <ProductNDC>72189-447</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230320</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203147</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>10</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>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230320</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use  Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.  Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets, USP contain rizatriptan benzoate, USP a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate, USP is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. [1]. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients. lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, ferric oxide (red), and magnesium stearate.</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-512-18</NDCCode>
    <PackageDescription>18 TABLET in 1 BOTTLE (72189-512-18) </PackageDescription>
    <NDC11Code>72189-0512-18</NDC11Code>
    <ProductNDC>72189-512</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230911</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202490</ApplicationNumber>
    <LabelerName>Direct_Rx</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>5</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>2025-01-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230911</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use. Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate tablets USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H­-indole-3-ethanamine monobenzoate and its structural formula is:. [Chemical Structure]. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.35. Rizatriptan benzoate is a white to almost white crystalline powder that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate tablets USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: corn starch, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (maize).</Description>
  </NDC>
  <NDC>
    <NDCCode>72189-609-18</NDCCode>
    <PackageDescription>18 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72189-609-18) </PackageDescription>
    <NDC11Code>72189-0609-18</NDC11Code>
    <ProductNDC>72189-609</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rizatriptan Benzoate Odt</ProprietaryName>
    <NonProprietaryName>Rizatriptan Benzoate Odt</NonProprietaryName>
    <DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250120</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203146</ApplicationNumber>
    <LabelerName>Direct_rx</LabelerName>
    <SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
    <StrengthNumber>10</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>2026-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use  Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks.  Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].  Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks.  Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.</IndicationAndUsage>
    <Description>Rizatriptan benzoate orally disintegrating tablets, USP contain rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D ) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: [structure]. Its molecular formula is C15H19N5C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate, USP is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan benzoate orally disintegrating tablets, USP are available for oral administration in strengths of 5 mg and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each orally disintegrating tablet contains following inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, carboxymethyl cellulose calcium, magnesium stearate, mannitol, aspartame, and peppermint flavor. USP Dissolution Test 2.</Description>
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  <NDC>
    <NDCCode>0597-0108-54</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0597-0108-54)  / 60 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>00597-0108-54</NDC11Code>
    <ProductNDC>0597-0108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022512</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>110</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170707</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&amp;C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0597-0108-60</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (0597-0108-60)  / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00597-0108-60</NDC11Code>
    <ProductNDC>0597-0108</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151123</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022512</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>110</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&amp;C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0597-0355-09</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (0597-0355-09)  / 60 CAPSULE in 1 BOTTLE</PackageDescription>
    <NDC11Code>00597-0355-09</NDC11Code>
    <ProductNDC>0597-0355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110808</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022512</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&amp;C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0597-0355-56</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (0597-0355-56)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00597-0355-56</NDC11Code>
    <ProductNDC>0597-0355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110808</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022512</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170728</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&amp;C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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    <NDC11Code>00597-0360-55</NDC11Code>
    <ProductNDC>0597-0360</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate Mesylate</NonProprietaryName>
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    <StartMarketingDate>20170728</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022512</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170728</StartMarketingDatePackage>
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    <IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&amp;C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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  <NDC>
    <NDCCode>0597-0360-82</NDCCode>
    <PackageDescription>60 BLISTER PACK in 1 CARTON (0597-0360-82)  / 1 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>00597-0360-82</NDC11Code>
    <ProductNDC>0597-0360</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
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    <ApplicationNumber>NDA022512</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
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    <IndicationAndUsage>PRADAXA Capsules is a direct thrombin inhibitor indicated: 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1), 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2), 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5 ∙ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. PRADAXA Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid. The capsule shell is composed of black edible ink, carrageenan, FD&amp;C Blue No. 2 (150 mg and 110 mg capsules only), hypromellose, potassium chloride, and titanium dioxide.</Description>
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    <NDCCode>0597-0430-18</NDCCode>
    <PackageDescription>1 BAG in 1 CARTON (0597-0430-18)  / 60 PELLET in 1 BAG</PackageDescription>
    <NDC11Code>00597-0430-18</NDC11Code>
    <ProductNDC>0597-0430</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pradaxa</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
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    <StartMarketingDate>20220316</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA214358</ApplicationNumber>
    <LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-01</LastUpdate>
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    <IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
    <Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
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    <PackageDescription>3 BLISTER PACK in 1 CARTON (0904-7253-04)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) </PackageDescription>
    <NDC11Code>00904-7253-04</NDC11Code>
    <ProductNDC>0904-7253</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208040</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&amp;C red #40 &amp; FD&amp;C blue #1 (150 mg and 110 mg), FD&amp;C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide &amp; potassium hydroxide.</Description>
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    <PackageDescription>6 BLISTER PACK in 1 CARTON (0904-7253-68)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) </PackageDescription>
    <NDC11Code>00904-7253-68</NDC11Code>
    <ProductNDC>0904-7253</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208040</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&amp;C red #40 &amp; FD&amp;C blue #1 (150 mg and 110 mg), FD&amp;C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide &amp; potassium hydroxide.</Description>
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    <PackageDescription>6 BLISTER PACK in 1 CARTON (0904-7254-68)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7254-35) </PackageDescription>
    <NDC11Code>00904-7254-68</NDC11Code>
    <ProductNDC>0904-7254</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208040</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>110</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&amp;C red #40 &amp; FD&amp;C blue #1 (150 mg and 110 mg), FD&amp;C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide &amp; potassium hydroxide.</Description>
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    <PackageDescription>2 BLISTER PACK in 1 CARTON (0904-7255-10)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) </PackageDescription>
    <NDC11Code>00904-7255-10</NDC11Code>
    <ProductNDC>0904-7255</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208040</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&amp;C red #40 &amp; FD&amp;C blue #1 (150 mg and 110 mg), FD&amp;C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide &amp; potassium hydroxide.</Description>
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    <PackageDescription>6 BLISTER PACK in 1 CARTON (0904-7255-68)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) </PackageDescription>
    <NDC11Code>00904-7255-68</NDC11Code>
    <ProductNDC>0904-7255</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE, COATED PELLETS</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250623</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208040</ApplicationNumber>
    <LabelerName>Major Pharmaceuticals</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3) , 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5)  , 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate. The empirical formula is C34H41N7O5⋅ CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to pale yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran Etexilate Capsules are supplied in 75 mg, 110 mg, and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: Butylated hydroxy toluene, citric acid monohydrate crystal, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, macrogol, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol 600, polyvinyl alcohol, povidone (k-value-25), sodium bicarbonate, talc, tartaric acid and titanium dioxide. The capsule shell is composed of hypromellose, titanium dioxide, FD&amp;C red #40 &amp; FD&amp;C blue #1 (150 mg and 110 mg), FD&amp;C yellow #6 (75 mg and 150 mg). The imprinting ink contains shellac, propylene glycol, strong ammonia solution, black iron oxide &amp; potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>30142-126-24</NDCCode>
    <PackageDescription>24 PATCH in 1 BOX (30142-126-24) </PackageDescription>
    <NDC11Code>30142-0126-24</NDC11Code>
    <ProductNDC>30142-126</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Salicylic Acid</ProprietaryName>
    <NonProprietaryName>Medicated Plantar Wart Remover</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120130</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M028</ApplicationNumber>
    <LabelerName>Kroger Co.</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/241</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>31722-621-32</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (31722-621-32)  / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>31722-0621-32</NDC11Code>
    <ProductNDC>31722-621</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200506</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207961</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated:  To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1)  For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2)  To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3).  For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4).  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5)  To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is N-[[2-[[[4-[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alanine ethyl ester, methanesulfonate. The empirical formula is C 34H 41N 7O 5.CH 3SO 3H and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow color powder. Sparingly soluble in methanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, sugar spheres (sucrose and corn starch), talc and tartaric acid. The capsule shell is composed of iron oxide red, iron oxide yellow, hypromellose and titanium dioxide. The capsules are printed with black ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-621-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (31722-621-60) </PackageDescription>
    <NDC11Code>31722-0621-60</NDC11Code>
    <ProductNDC>31722-621</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200506</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207961</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated:  To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1)  For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2)  To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3).  For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4).  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5)  To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is N-[[2-[[[4-[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alanine ethyl ester, methanesulfonate. The empirical formula is C 34H 41N 7O 5.CH 3SO 3H and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow color powder. Sparingly soluble in methanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, sugar spheres (sucrose and corn starch), talc and tartaric acid. The capsule shell is composed of iron oxide red, iron oxide yellow, hypromellose and titanium dioxide. The capsules are printed with black ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-622-32</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (31722-622-32)  / 6 CAPSULE in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>31722-0622-32</NDC11Code>
    <ProductNDC>31722-622</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200506</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207961</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated:  To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1)  For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2)  To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3).  For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4).  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5)  To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is N-[[2-[[[4-[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alanine ethyl ester, methanesulfonate. The empirical formula is C 34H 41N 7O 5.CH 3SO 3H and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow color powder. Sparingly soluble in methanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, sugar spheres (sucrose and corn starch), talc and tartaric acid. The capsule shell is composed of iron oxide red, iron oxide yellow, hypromellose and titanium dioxide. The capsules are printed with black ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>31722-622-60</NDCCode>
    <PackageDescription>60 CAPSULE in 1 BOTTLE (31722-622-60) </PackageDescription>
    <NDC11Code>31722-0622-60</NDC11Code>
    <ProductNDC>31722-622</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dabigatran Etexilate</ProprietaryName>
    <NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200506</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207961</ApplicationNumber>
    <LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200506</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated:  To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1)  For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2)  To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3).  For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4).  For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5)  To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6).</IndicationAndUsage>
    <Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is N-[[2-[[[4-[(hexyloxy)carbonyl]amino]iminomethyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alanine ethyl ester, methanesulfonate. The empirical formula is C 34H 41N 7O 5.CH 3SO 3H and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is:. Dabigatran etexilate mesylate is a yellow-white to yellow color powder. Sparingly soluble in methanol. Dabigatran etexilate capsules are supplied in 75 mg, 110 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate), 110 mg dabigatran etexilate (equivalent to 126.83 mg dabigatran etexilate mesylate), or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, sugar spheres (sucrose and corn starch), talc and tartaric acid. The capsule shell is composed of iron oxide red, iron oxide yellow, hypromellose and titanium dioxide. The capsules are printed with black ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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