RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68770-210-42</NDCCode>
    <PackageDescription>600 PELLET in 1 TUBE (68770-210-42) </PackageDescription>
    <NDC11Code>68770-0210-42</NDC11Code>
    <ProductNDC>68770-210</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cataract</ProprietaryName>
    <NonProprietaryName>Calcium Fluoride, Tribasic Calcium Phosphate, Causticum, Jacobaea Maritima Whole, Euphrasia Stricta, Sepia Officinalis Juice, Silicon Dioxide</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220427</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Natural Ophthalmics, Inc</LabelerName>
    <SubstanceName>CALCIUM FLUORIDE; CAUSTICUM; EUPHRASIA STRICTA; JACOBAEA MARITIMA WHOLE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
    <StrengthNumber>12; 12; 7; 6; 7; 13; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>According to homeopathic indications, these ingredients are intended to stimulate and help the body counteract the symptoms of cataracts.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68770-140-42</NDCCode>
    <PackageDescription>600 PELLET in 1 BOTTLE (68770-140-42) </PackageDescription>
    <NDC11Code>68770-0140-42</NDC11Code>
    <ProductNDC>68770-140</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Floater</ProprietaryName>
    <NonProprietaryName>Chelidonium Majus Whole, Potassium Sulfate, Sodium Chloride, Phosphorus, Physostigma Venenosum Seed, Sepia Officinalis Juice, Silicon Dioxide</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220427</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Natural Ophthalmics, Inc</LabelerName>
    <SubstanceName>CHELIDONIUM MAJUS WHOLE; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED; POTASSIUM SULFATE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>6; 12; 12; 10; 7; 12; 10</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: According to homeopathic indications, these ingredients offer temporary relief for the symptoms of eye floaters.†.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68770-190-42</NDCCode>
    <PackageDescription>600 PELLET in 1 BOTTLE (68770-190-42) </PackageDescription>
    <NDC11Code>68770-0190-42</NDC11Code>
    <ProductNDC>68770-190</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Macula</ProprietaryName>
    <NonProprietaryName>Calcium Fluoride, Calcium Phosphate, Carbon Disulfide, Dibasic Potassium Phosphate, Sodium Chloride</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220427</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Natural Ophthalmics, Inc</LabelerName>
    <SubstanceName>CALCIUM FLUORIDE; CALCIUM PHOSPHATE; CARBON DISULFIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE</SubstanceName>
    <StrengthNumber>12; 10; 11; 7; 9</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: According to homeopathic indications, these ingredients are intended to stimulate and help the body counteract the symptoms of macular degeneration.† .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68770-220-42</NDCCode>
    <PackageDescription>600 PELLET in 1 BOTTLE (68770-220-42) </PackageDescription>
    <NDC11Code>68770-0220-42</NDC11Code>
    <ProductNDC>68770-220</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glaucoma</ProprietaryName>
    <NonProprietaryName>Arnica Montana, Gelsemium Sempervirens, Lycopodium Clavatum, Phosphorus, Physostigma Venenosum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220427</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Natural Ophthalmics, Inc</LabelerName>
    <SubstanceName>ARNICA MONTANA; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PHYSOSTIGMA VENENOSUM SEED</SubstanceName>
    <StrengthNumber>12; 6; 12; 12; 12</StrengthNumber>
    <StrengthUnit>[hp_X]/1; [hp_C]/1; [hp_C]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220427</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses: According to homeopathic indications, these ingredients offer temporary relief for the symptoms of glaucoma.†.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>11054-001-42</NDCCode>
    <PackageDescription>8800 L in 1 CYLINDER (11054-001-42) </PackageDescription>
    <NDC11Code>11054-0001-42</NDC11Code>
    <ProductNDC>11054-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Air</ProprietaryName>
    <NonProprietaryName>Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19971106</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA206023</ApplicationNumber>
    <LabelerName>AIRGAS USA, LLC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11054-110-42</NDCCode>
    <PackageDescription>8800 L in 1 CYLINDER (11054-110-42) </PackageDescription>
    <NDC11Code>11054-0110-42</NDC11Code>
    <ProductNDC>11054-110</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Air</ProprietaryName>
    <NonProprietaryName>Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19971106</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205845</ApplicationNumber>
    <LabelerName>AIRGAS USA, LLC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19971106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49204-004-12</NDCCode>
    <PackageDescription>42 L in 1 CYLINDER (49204-004-12) </PackageDescription>
    <NDC11Code>49204-0004-12</NDC11Code>
    <ProductNDC>49204-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Air</ProprietaryName>
    <NonProprietaryName>Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>19770701</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205712</ApplicationNumber>
    <LabelerName>HARTMAN BROTHERS, INC.</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19770701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>52747-620-10</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 BOX (52747-620-10)  &gt; 4 CAPSULE in 1 BLISTER PACK (52747-620-04) </PackageDescription>
    <NDC11Code>52747-0620-10</NDC11Code>
    <ProductNDC>52747-620</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Concept Ob</ProprietaryName>
    <NonProprietaryName>Vitamin Mineral Supplement</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>U.S. Pharmaceutical Corporation</LabelerName>
    <SubstanceName>FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; MANGANESE SULFATE; ZINC SULFATE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>42.5; 42.5; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.</IndicationAndUsage>
    <Description>DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine.</Description>
  </NDC>
  <NDC>
    <NDCCode>52747-620-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (52747-620-30) </PackageDescription>
    <NDC11Code>52747-0620-30</NDC11Code>
    <ProductNDC>52747-620</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Concept Ob</ProprietaryName>
    <NonProprietaryName>Vitamin Mineral Supplement</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090101</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>U.S. Pharmaceutical Corporation</LabelerName>
    <SubstanceName>FERROUS FUMARATE; IRON; ASCORBIC ACID; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACIN; CALCIUM PANTOTHENATE; PYRIDOXINE HYDROCHLORIDE; BIOTIN; CYANOCOBALAMIN; CUPRIC SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM; MANGANESE SULFATE; ZINC SULFATE, UNSPECIFIED FORM</SubstanceName>
    <StrengthNumber>42.5; 42.5; 210; 1; 5; 5; 20; 7; 25; 300; 10; 800; 6.9; 1.3; 18.2</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-11-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>INDICATIONS: Concept OBTM is a prenatal supplement designed to improve the nutritional status for women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Concept OBTM may also be used to improve the nutritional status of women before conception.</IndicationAndUsage>
    <Description>DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .....................................130 mg (Equivalent to about 42.5 mg of Elemental Iron) PolysaccharideIronComplex .....................................92.4mg (Equivalent to about 42.5 mg of Elemental Iron) Vitamin C (from ProAscorb C‡)..................................... 210 mg Folic Acid ................................................................................... 1 mg Thiamine Mononitrate (B1)................................................. 5 mg Riboflavin (B2).......................................................................... 5 mg Niacin (B3)...............................................................................20 mg d-Calcium Pantothenate (B5)............................................. 7 mg Pyridoxine HCl (B6) ..............................................................25 mg Biotin (B7)........................................................................... 300 mcg Cyanocobalamin (B12) .....................................................10 mcg Copper (as Copper Sulfate)..........................................800 mcg Magnesium (as Magnesium Sulfate)............................6.9 mg Manganese (as Manganese Sulfate).............................1.3 mg Zinc (as Zinc Sulfate) ....................................................... 18.2 mg Inactive Ingredients: Hypromellose, Silicon Dioxide, Magnesium Stearate, Carmine, and Candurin Silver Fine.</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-651-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (61314-651-01)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>61314-0651-01</NDC11Code>
    <ProductNDC>61314-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250222</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761373</ApplicationNumber>
    <LabelerName>SANDOZ INC</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-651-94</NDCCode>
    <PackageDescription>1 VIAL in 1 CARTON (61314-651-94)  / .5 mL in 1 VIAL</PackageDescription>
    <NDC11Code>61314-0651-94</NDC11Code>
    <ProductNDC>61314-651</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250222</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761373</ApplicationNumber>
    <LabelerName>SANDOZ INC</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250623</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-652-01</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (61314-652-01)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>61314-0652-01</NDC11Code>
    <ProductNDC>61314-652</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250222</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761373</ApplicationNumber>
    <LabelerName>SANDOZ INC</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>61314-654-94</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (61314-654-94)  / 26 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>61314-0654-94</NDC11Code>
    <ProductNDC>61314-654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250222</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761425</ApplicationNumber>
    <LabelerName>SANDOZ INC</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/26mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250222</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>68788-8622-8</NDCCode>
    <PackageDescription>210 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8622-8) </PackageDescription>
    <NDC11Code>68788-8622-08</NDC11Code>
    <ProductNDC>68788-8622</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omeprazole</ProprietaryName>
    <NonProprietaryName>Omeprazole</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240405</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075576</ApplicationNumber>
    <LabelerName>Preferred Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>OMEPRAZOLE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-06-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Omeprazole is a proton pump inhibitor (PPI) indicated for the:.  Treatment of active duodenal ulcer in adults (1.1).  Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults (1.2).  Treatment of active benign gastric ulcer in adults (1.3).  Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older (1.4).  Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older (1.6).  Pathologic hypersecretory conditions in adults (1.7).</IndicationAndUsage>
    <Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&amp;C Red No. 28, FD&amp;C Blue No. 1, FD&amp;C Red No. 40, FD&amp;C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&amp;C Yellow No. 10 aluminum lake, FD&amp;C Blue No. 1 aluminum lake, FD&amp;C Blue No. 2 aluminum lake, FD&amp;C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>72572-210-10</NDCCode>
    <PackageDescription>10 VIAL in 1 CARTON (72572-210-10)  / 4 mL in 1 VIAL (72572-210-01) </PackageDescription>
    <NDC11Code>72572-0210-10</NDC11Code>
    <ProductNDC>72572-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bumetanide</ProprietaryName>
    <NonProprietaryName>Bumetanide</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
    <StartMarketingDate>20260801</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074441</ApplicationNumber>
    <LabelerName>Civica, Inc.</LabelerName>
    <SubstanceName>BUMETANIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-08-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260801</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bumetanide injection is indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
    <Description>Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg per mL), for intravenous or intramuscular injection as a sterile solution. Each mL contains bumetanide 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 to 7.8 with sodium hydroxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder, slightly soluble in water, soluble in alkaline solutions, having the following structural formula:. C17H20N2O5S        Molecular weight: 364.42.</Description>
  </NDC>
  <NDC>
    <NDCCode>72834-210-30</NDCCode>
    <PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72834-210-30) </PackageDescription>
    <NDC11Code>72834-0210-30</NDC11Code>
    <ProductNDC>72834-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rabeprazole Sodium Delayed-release</ProprietaryName>
    <NonProprietaryName>Rabeprazole Sodium</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190627</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA204736</ApplicationNumber>
    <LabelerName>Sarras Health, LLC</LabelerName>
    <SubstanceName>RABEPRAZOLE SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190627</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Rabeprazole sodium delayed-release capsules are indicated for treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients 1 to 11 years of age for up to 12 weeks.</IndicationAndUsage>
    <Description>The active ingredient in rabeprazole sodium delayed-release capsules is rabeprazole sodium, which is a proton pump inhibitor. It is a substituted benzimidazole known chemically as 2-[[[4-(3-methoxypropoxy)-3-methyl-2-pyridinyl]-methyl]sulfinyl]-1H–benzimidazole sodium salt. It has an empirical formula of C18H20N3NaO3S and a molecular weight of 381.42. Rabeprazole sodium is a white to slightly yellowish-white solid. It is very soluble in water and methanol, freely soluble in ethanol, chloroform, and ethyl acetate and insoluble in ether and n-hexane. The stability of rabeprazole sodium is a function of pH; it is rapidly degraded in acid media, and is more stable under alkaline conditions. The structural figure is. Figure 1. Rabeprazole sodium delayed-release capsules (sprinkle) are available for oral administration as 10 mg rabeprazole sodium delayed-release capsules containing enteric coated granules. Rabeprazole sodium delayed-release capsules contain granules of rabeprazole sodium in a hard hypromellose capsule. Inactive ingredients are colloidal silicon dioxide, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, talc, titanium dioxide, carrageenan, potassium chloride, FD&amp;C Yellow, No. 6 (in the 10 mg capsule), and gray printing ink.</Description>
  </NDC>
  <NDC>
    <NDCCode>73468-006-42</NDCCode>
    <PackageDescription>8800 L in 1 CYLINDER (73468-006-42) </PackageDescription>
    <NDC11Code>73468-0006-42</NDC11Code>
    <ProductNDC>73468-006</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Air</ProprietaryName>
    <NonProprietaryName>Air</NonProprietaryName>
    <DosageFormName>GAS</DosageFormName>
    <RouteName>RESPIRATORY (INHALATION)</RouteName>
    <StartMarketingDate>20191210</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA205765</ApplicationNumber>
    <LabelerName>Magnegas Welding Supply-South, LLC</LabelerName>
    <SubstanceName>OXYGEN</SubstanceName>
    <StrengthNumber>210</StrengthNumber>
    <StrengthUnit>mL/L</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>79378-210-30</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (79378-210-30)  / 30 TABLET in 1 BOTTLE</PackageDescription>
    <NDC11Code>79378-0210-30</NDC11Code>
    <ProductNDC>79378-210</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Livmarli</ProprietaryName>
    <NonProprietaryName>Maralixibat Chloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250410</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219485</ApplicationNumber>
    <LabelerName>Mirum Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>MARALIXIBAT CHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA], Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250410</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for: 1 the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). (1.1), 2 the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). (1.2)oLimitations of Use:LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein. (14.2).</IndicationAndUsage>
    <Description>LIVMARLI (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor. Maralixibat is present as a chloride salt with the chemical name 1-[[4-[[4-[(4R,5R)-3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride. The molecular formula of maralixibat chloride is C40H56ClN3O4S with a molecular weight of 710.42. It has the following chemical structure. LIVMARLI oral solution is supplied in a multiple-dose bottle containing 9.5 mg of maralixibat per mL (equivalent to 10 mg of maralixibat chloride per mL), or containing 19 mg of maralixibat per mL (equivalent to 20 mg of maralixibat chloride per mL). The oral solution contains the following inactive ingredients: edetate disodium, grape flavor, propylene glycol, purified water, and sucralose. The pH of the oral solution is 3.8 – 4.8. LIVMARLI tablets are available in 10 mg, 15 mg, 20 mg and 30 mg strengths of maralixibat (equivalent to 10.5 mg, 15.8 mg, 21 mg, and 31.6 mg maralixibat chloride, respectively). The tablets contain the following inactive ingredients: crospovidone, glyceryl distearate, lactose monohydrate, microcrystalline cellulose, and silicon dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>82009-160-11</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (82009-160-11)  / .5 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>82009-0160-11</NDC11Code>
    <ProductNDC>82009-160</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ustekinumab-ttwe</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250415</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761373</ApplicationNumber>
    <LabelerName>Quallent Pharmaceuticals Health LLC</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>45</StrengthNumber>
    <StrengthUnit>mg/.5mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250415</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>USTEKINUMAB-TTWE is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. USTEKINUMAB-TTWE (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. USTEKINUMAB-TTWE for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Each 0.5 mL prefilled syringe, or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). USTEKINUMAB-TTWE for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
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    <IndicationAndUsage>USTEKINUMAB-TTWE is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. USTEKINUMAB-TTWE (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. USTEKINUMAB-TTWE for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Each 0.5 mL prefilled syringe, or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). USTEKINUMAB-TTWE for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
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    <IndicationAndUsage>USTEKINUMAB-TTWE is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. USTEKINUMAB-TTWE (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. USTEKINUMAB-TTWE for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Each 0.5 mL prefilled syringe, or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). USTEKINUMAB-TTWE for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
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    <IndicationAndUsage>USTEKINUMAB-TTWE is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. USTEKINUMAB-TTWE (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. USTEKINUMAB-TTWE for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Each 0.5 mL prefilled syringe, or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). USTEKINUMAB-TTWE for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
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    <LabelerName>Cordavis Limited</LabelerName>
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    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
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    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
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    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
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    <NDC11Code>83457-0652-01</NDC11Code>
    <ProductNDC>83457-652</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761373</ApplicationNumber>
    <LabelerName>Cordavis Limited</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>83457-652-96</NDCCode>
    <PackageDescription>1 SYRINGE in 1 CARTON (83457-652-96)  / 1 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>83457-0652-96</NDC11Code>
    <ProductNDC>83457-652</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20250501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761373</ApplicationNumber>
    <LabelerName>Cordavis Limited</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>90</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250814</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
  <NDC>
    <NDCCode>83457-654-94</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (83457-654-94)  / 26 mL in 1 VIAL, SINGLE-USE</PackageDescription>
    <NDC11Code>83457-0654-94</NDC11Code>
    <ProductNDC>83457-654</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pyzchiva</ProprietaryName>
    <NonProprietaryName>Ustekinumab-ttwe</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20250501</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761425</ApplicationNumber>
    <LabelerName>Cordavis Limited</LabelerName>
    <SubstanceName>USTEKINUMAB</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/26mL</StrengthUnit>
    <Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-02-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>PYZCHIVA is a human interleukin-12 and -23 antagonist indicated for the treatment of:Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn's disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
    <Description>Ustekinumab-ttwe, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-ttwe is produced in a Chinese hamster ovary cell line. The manufacturing process contains steps for the clearance of viruses. Ustekinumab-ttwe is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. PYZCHIVA (ustekinumab-ttwe) injection is a clear, colorless to light yellow, sterile and preservative-free solution with pH of 5.7– 6.3. PYZCHIVA for Subcutaneous Use. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 29 gauge fixed ½ inch needle and as 45 mg of ustekinumab-ttwe in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover. Available as 45 mg of ustekinumab-ttwe in 0.5 mL and 90 mg of ustekinumab-ttwe in 1 mL, supplied as a sterile solution in a single-dose prefilled autoinjector. Each 0.5 mL prefilled syringe, prefilled PYZCHIVA AUTOINJECTOR or vial delivers 45 mg ustekinumab-ttwe, histidine (0.095 mg), histidine hydrochloride monohydrate (0.405 mg), polysorbate 80 (0.02 mg), and sucrose (42.5 mg). Each 1 mL prefilled syringe or prefilled PYZCHIVA AUTOINJECTOR delivers 90 mg ustekinumab-ttwe, histidine (0.19 mg), histidine hydrochloride monohydrate (0.81 mg), polysorbate 80 (0.04 mg), and sucrose (85 mg). PYZCHIVA for Intravenous Infusion. Available as 130 mg of ustekinumab-ttwe in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-ttwe, edetate disodium (0.52 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), polysorbate 80 (10.4 mg) and sucrose (2,210 mg).</Description>
  </NDC>
</NDCList>