RESTful Lookup — Test-Drive (2007 – 2026)

{
  "NDC": [
    {
      "NDCCode": "35573-445-25",
      "PackageDescription": "25 POUCH in 1 CARTON (35573-445-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "35573-0445-25",
      "ProductNDC": "35573-445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levalbuterol",
      "NonProprietaryName": "Levalbuterol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203653",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
      "StrengthNumber": "1.25",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
      "Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
    },
    {
      "NDCCode": "35573-443-25",
      "PackageDescription": "25 POUCH in 1 CARTON (35573-443-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "35573-0443-25",
      "ProductNDC": "35573-443",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levalbuterol",
      "NonProprietaryName": "Levalbuterol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203653",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
      "StrengthNumber": ".31",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
      "Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
    },
    {
      "NDCCode": "35573-444-25",
      "PackageDescription": "25 POUCH in 1 CARTON (35573-444-25)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "35573-0444-25",
      "ProductNDC": "35573-444",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Levalbuterol",
      "NonProprietaryName": "Levalbuterol Hydrochloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "RESPIRATORY (INHALATION)",
      "StartMarketingDate": "20210401",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA203653",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
      "StrengthNumber": ".63",
      "StrengthUnit": "mg/3mL",
      "Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-06-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
      "Description": "Levalbuterol Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5)."
    },
    {
      "NDCCode": "12634-445-79",
      "PackageDescription": "25 TABLET in 1 BOTTLE (12634-445-79)",
      "NDC11Code": "12634-0445-79",
      "ProductNDC": "12634-445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Hydrochlorothiazide",
      "NonProprietaryName": "Hydrochlorothiazide",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19961221",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA084325",
      "LabelerName": "Apotheca, Inc.",
      "SubstanceName": "HYDROCHLOROTHIAZIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy).Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.",
      "Description": "Hydrochlorothiazide is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula."
    },
    {
      "NDCCode": "51655-445-25",
      "PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (51655-445-25) ",
      "NDC11Code": "51655-0445-25",
      "ProductNDC": "51655-445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Clonidine Hydrochloride",
      "NonProprietaryName": "Clonidine Hydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20201001",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA070925",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "CLONIDINE HYDROCHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20220826",
      "SamplePackage": "N",
      "IndicationAndUsage": "Clonidine hydrochloride tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.",
      "Description": "Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. Clonidine hydrochloride tablets USP contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. The 0.1 mg also contains D&C yellow #10 aluminum lake, and the 0.3 mg contains D&C yellow #10 aluminum lake and FD&C blue #1 aluminum lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. C 9H 9Cl 2N 3  HCl       Mol. Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
    },
    {
      "NDCCode": "35573-415-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-415-30) ",
      "NDC11Code": "35573-0415-30",
      "ProductNDC": "35573-415",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-416-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-416-30) ",
      "NDC11Code": "35573-0416-30",
      "ProductNDC": "35573-416",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "18",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-417-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-417-30) ",
      "NDC11Code": "35573-0417-30",
      "ProductNDC": "35573-417",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-418-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-418-30) ",
      "NDC11Code": "35573-0418-30",
      "ProductNDC": "35573-418",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-419-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-419-30) ",
      "NDC11Code": "35573-0419-30",
      "ProductNDC": "35573-419",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "60",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-420-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-420-30) ",
      "NDC11Code": "35573-0420-30",
      "ProductNDC": "35573-420",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-421-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (35573-421-30) ",
      "NDC11Code": "35573-0421-30",
      "ProductNDC": "35573-421",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Atomoxetine",
      "NonProprietaryName": "Atomoxetine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20170530",
      "EndMarketingDate": "20250131",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA079016",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-02-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20170530",
      "EndMarketingDatePackage": "20250131",
      "SamplePackage": "N",
      "IndicationAndUsage": "Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1).",
      "Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac."
    },
    {
      "NDCCode": "35573-436-02",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-436-02) ",
      "NDC11Code": "35573-0436-02",
      "ProductNDC": "35573-436",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loxapine",
      "NonProprietaryName": "Loxapine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076868",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LOXAPINE SUCCINATE",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
      "Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
    },
    {
      "NDCCode": "35573-437-02",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-437-02) ",
      "NDC11Code": "35573-0437-02",
      "ProductNDC": "35573-437",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loxapine",
      "NonProprietaryName": "Loxapine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076868",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LOXAPINE SUCCINATE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
      "Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
    },
    {
      "NDCCode": "35573-438-02",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-438-02) ",
      "NDC11Code": "35573-0438-02",
      "ProductNDC": "35573-438",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loxapine",
      "NonProprietaryName": "Loxapine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076868",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LOXAPINE SUCCINATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
      "Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
    },
    {
      "NDCCode": "35573-439-02",
      "PackageDescription": "100 CAPSULE in 1 BOTTLE (35573-439-02) ",
      "NDC11Code": "35573-0439-02",
      "ProductNDC": "35573-439",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Loxapine",
      "NonProprietaryName": "Loxapine",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20210501",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA076868",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "LOXAPINE SUCCINATE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2024-10-08",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210501",
      "SamplePackage": "N",
      "IndicationAndUsage": "Loxapine capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.",
      "Description": "Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine. It is present as the succinate salt. Each capsule for oral administration, contains loxapine succinate, USP 6.8 mg, 13.6 mg, 34.0 mg or 68.0 mg equivalent to 5 mg, 10 mg, 25 mg or 50 mg of loxapine base respectively. It also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and titanium dioxide. The 5 mg capsule contains FD&C Blue #1 and FD&C Yellow #6; the 10 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1, D&C Yellow #10 and FD&C Yellow #6; the 25 mg capsule contains FDA/E172 Yellow Iron Oxide, FD&C Blue #1 and D&C Yellow #10; the 50 mg capsule contains FDA/E172 Yellow Iron Oxide and FD&C Blue #1. The ink ingredients are common for all strengths: the capsule imprint ink contains shellac glaze, ferrosoferric oxide, butyl alcohol, propylene glycol, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow #10 Aluminum Lake, and FD&C Blue #1 Aluminum Lake."
    },
    {
      "NDCCode": "35573-464-02",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-464-02) ",
      "NDC11Code": "35573-0464-02",
      "ProductNDC": "35573-464",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "EndMarketingDate": "20280229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212037",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "1.25; 1.25; 1.25; 1.25",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191216",
      "EndMarketingDatePackage": "20280229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.   The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
    },
    {
      "NDCCode": "35573-465-02",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-465-02) ",
      "NDC11Code": "35573-0465-02",
      "ProductNDC": "35573-465",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "EndMarketingDate": "20280229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212037",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "2.5; 2.5; 2.5; 2.5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191216",
      "EndMarketingDatePackage": "20280229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.   The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
    },
    {
      "NDCCode": "35573-466-02",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-466-02) ",
      "NDC11Code": "35573-0466-02",
      "ProductNDC": "35573-466",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "EndMarketingDate": "20280229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212037",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "3.75; 3.75; 3.75; 3.75",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191216",
      "EndMarketingDatePackage": "20280229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.   The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
    },
    {
      "NDCCode": "35573-467-02",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-467-02) ",
      "NDC11Code": "35573-0467-02",
      "ProductNDC": "35573-467",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "EndMarketingDate": "20280229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212037",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "5; 5; 5; 5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191216",
      "EndMarketingDatePackage": "20280229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.   The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
    },
    {
      "NDCCode": "35573-468-02",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-468-02) ",
      "NDC11Code": "35573-0468-02",
      "ProductNDC": "35573-468",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "EndMarketingDate": "20280229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212037",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "6.25; 6.25; 6.25; 6.25",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191216",
      "EndMarketingDatePackage": "20280229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.   The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
    },
    {
      "NDCCode": "35573-469-02",
      "PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (35573-469-02) ",
      "NDC11Code": "35573-0469-02",
      "ProductNDC": "35573-469",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
      "DosageFormName": "CAPSULE, EXTENDED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20191216",
      "EndMarketingDate": "20280229",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA212037",
      "LabelerName": "Burel Pharmaceuticals, LLC",
      "SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE",
      "StrengthNumber": "7.5; 7.5; 7.5; 7.5",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
      "DEASchedule": "CII",
      "Status": "Active",
      "LastUpdate": "2025-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20191216",
      "EndMarketingDatePackage": "20280229",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1).",
      "Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.   The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac."
    },
    {
      "NDCCode": "0002-1445-09",
      "PackageDescription": "3 SYRINGE in 1 CARTON (0002-1445-09)  / 1 mL in 1 SYRINGE (0002-1445-01) ",
      "NDC11Code": "00002-1445-09",
      "ProductNDC": "0002-1445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160322",
      "SamplePackage": "N",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-1445-11",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0002-1445-11)  / 1 mL in 1 SYRINGE (0002-1445-01) ",
      "NDC11Code": "00002-1445-11",
      "ProductNDC": "0002-1445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160322",
      "SamplePackage": "N",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-1445-27",
      "PackageDescription": "2 SYRINGE in 1 CARTON (0002-1445-27)  / 1 mL in 1 SYRINGE (0002-1445-01) ",
      "NDC11Code": "00002-1445-27",
      "ProductNDC": "0002-1445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160322",
      "SamplePackage": "N",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-1445-61",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0002-1445-61)  / 1 mL in 1 SYRINGE",
      "NDC11Code": "00002-1445-61",
      "ProductNDC": "0002-1445",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160419",
      "SamplePackage": "Y",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-7724-11",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0002-7724-11)  / 1 mL in 1 SYRINGE (0002-7724-01) ",
      "NDC11Code": "00002-7724-11",
      "ProductNDC": "0002-7724",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20160322",
      "SamplePackage": "N",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-7724-99",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0002-7724-99)  / 1 mL in 1 SYRINGE",
      "NDC11Code": "00002-7724-99",
      "ProductNDC": "0002-7724",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180116",
      "SamplePackage": "Y",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-8900-11",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0002-8900-11)  / .25 mL in 1 SYRINGE (0002-8900-01) ",
      "NDC11Code": "00002-8900-11",
      "ProductNDC": "0002-8900",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20240202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/.25mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240202",
      "SamplePackage": "N",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    },
    {
      "NDCCode": "0002-8905-11",
      "PackageDescription": "1 SYRINGE in 1 CARTON (0002-8905-11)  / .5 mL in 1 SYRINGE (0002-8905-01) ",
      "NDC11Code": "00002-8905-11",
      "ProductNDC": "0002-8905",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Taltz",
      "NonProprietaryName": "Ixekizumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20240202",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125521",
      "LabelerName": "Eli Lilly and Company",
      "SubstanceName": "IXEKIZUMAB",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/.5mL",
      "Pharm_Classes": "Interleukin-17A Antagonist [EPC], Interleukin-17A Antagonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240202",
      "SamplePackage": "N",
      "IndicationAndUsage": "TALTZ® is a humanized interleukin-17A antagonist indicated for the treatment of: : 1 patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. (1.1) , 2 adults with active psoriatic arthritis. (1.2) , 3 adults with active ankylosing spondylitis. (1.3) , 4 adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation. (1.4) .",
      "Description": "Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. TALTZ injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe, 40 mg of ixekizumab in a 0.5 mL single-dose prefilled syringe, or 20 mg of ixekizumab in a 0.25 mL single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge ½ inch needle. The TALTZ 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. The TALTZ 40 mg prefilled syringe is manufactured to deliver 40 mg of ixekizumab. The TALTZ 20 mg prefilled syringe is manufactured to deliver 20 mg of ixekizumab. Each TALTZ 80 mg/mL single-dose autoinjector or TALTZ 80 mg/mL single-dose prefilled syringe is composed of ixekizumab (80 mg); Polysorbate 80, USP (0.3 mg); Sucrose, USP (80 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 40 mg/0.5 mL single-dose prefilled syringe is composed of ixekizumab (40 mg); Polysorbate 80, USP (0.15 mg); Sucrose, USP (40 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2. Each TALTZ 20 mg/0.25 mL single-dose prefilled syringe is composed of ixekizumab (20 mg); Polysorbate 80, USP (0.08 mg); Sucrose, USP (20 mg); and Water for Injection, USP. Sodium Hydroxide, USP-NF, may have been added to adjust pH. The TALTZ solution has a pH of 5.2 –  6.2."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"35573-445-25","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"35573-443-25","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"35573-444-25","ProprietaryName":"Levalbuterol","NonProprietaryName":"Levalbuterol Hydrochloride"},{"NDCCode":"12634-445-79","ProprietaryName":"Hydrochlorothiazide","NonProprietaryName":"Hydrochlorothiazide"},{"NDCCode":"51655-445-25","ProprietaryName":"Clonidine Hydrochloride","NonProprietaryName":"Clonidine Hydrochloride"},{"NDCCode":"35573-415-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-416-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-417-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-418-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-419-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-420-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-421-30","ProprietaryName":"Atomoxetine","NonProprietaryName":"Atomoxetine"},{"NDCCode":"35573-436-02","ProprietaryName":"Loxapine","NonProprietaryName":"Loxapine"},{"NDCCode":"35573-437-02","ProprietaryName":"Loxapine","NonProprietaryName":"Loxapine"},{"NDCCode":"35573-438-02","ProprietaryName":"Loxapine","NonProprietaryName":"Loxapine"},{"NDCCode":"35573-439-02","ProprietaryName":"Loxapine","NonProprietaryName":"Loxapine"},{"NDCCode":"35573-464-02","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"},{"NDCCode":"35573-465-02","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"},{"NDCCode":"35573-466-02","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"},{"NDCCode":"35573-467-02","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"},{"NDCCode":"35573-468-02","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"},{"NDCCode":"35573-469-02","ProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate","NonProprietaryName":"Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate"},{"NDCCode":"0002-1445-09","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-1445-11","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-1445-27","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-1445-61","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-7724-11","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-7724-99","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-8900-11","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"},{"NDCCode":"0002-8905-11","ProprietaryName":"Taltz","NonProprietaryName":"Ixekizumab"}]}
                    

<NDCList><NDC><NDCCode>35573-445-25</NDCCode><ProprietaryName>Levalbuterol</ProprietaryName><NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35573-443-25</NDCCode><ProprietaryName>Levalbuterol</ProprietaryName><NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35573-444-25</NDCCode><ProprietaryName>Levalbuterol</ProprietaryName><NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>12634-445-79</NDCCode><ProprietaryName>Hydrochlorothiazide</ProprietaryName><NonProprietaryName>Hydrochlorothiazide</NonProprietaryName></NDC><NDC><NDCCode>51655-445-25</NDCCode><ProprietaryName>Clonidine Hydrochloride</ProprietaryName><NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>35573-415-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-416-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-417-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-418-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-419-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-420-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-421-30</NDCCode><ProprietaryName>Atomoxetine</ProprietaryName><NonProprietaryName>Atomoxetine</NonProprietaryName></NDC><NDC><NDCCode>35573-436-02</NDCCode><ProprietaryName>Loxapine</ProprietaryName><NonProprietaryName>Loxapine</NonProprietaryName></NDC><NDC><NDCCode>35573-437-02</NDCCode><ProprietaryName>Loxapine</ProprietaryName><NonProprietaryName>Loxapine</NonProprietaryName></NDC><NDC><NDCCode>35573-438-02</NDCCode><ProprietaryName>Loxapine</ProprietaryName><NonProprietaryName>Loxapine</NonProprietaryName></NDC><NDC><NDCCode>35573-439-02</NDCCode><ProprietaryName>Loxapine</ProprietaryName><NonProprietaryName>Loxapine</NonProprietaryName></NDC><NDC><NDCCode>35573-464-02</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-465-02</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-466-02</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-467-02</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-468-02</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>35573-469-02</NDCCode><ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</ProprietaryName><NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName></NDC><NDC><NDCCode>0002-1445-09</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-1445-11</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-1445-27</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-1445-61</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-7724-11</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-7724-99</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-8900-11</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC><NDC><NDCCode>0002-8905-11</NDCCode><ProprietaryName>Taltz</ProprietaryName><NonProprietaryName>Ixekizumab</NonProprietaryName></NDC></NDCList>