{
"NDC": [
{
"NDCCode": "0456-2220-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-30) ",
"NDC11Code": "00456-2220-30",
"ProductNDC": "0456-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fetzima",
"NonProprietaryName": "Levomilnacipran Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130725",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204168",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LEVOMILNACIPRAN HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130725",
"SamplePackage": "N",
"IndicationAndUsage": "FETZIMA® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.",
"Description": "FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only)."
},
{
"NDCCode": "0456-2200-07",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0456-2200-07) / 1 KIT in 1 BLISTER PACK (0456-2200-65) * 2 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2220-00) * 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2240-00) ",
"NDC11Code": "00456-2200-07",
"ProductNDC": "0456-2200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fetzima",
"NonProprietaryName": "Levomilnacipran Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20230324",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204168",
"LabelerName": "Allergan, Inc.",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230324",
"SamplePackage": "Y",
"IndicationAndUsage": "FETZIMA® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.",
"Description": "FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only)."
},
{
"NDCCode": "0456-2220-07",
"PackageDescription": "40 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2220-07) ",
"NDC11Code": "00456-2220-07",
"ProductNDC": "0456-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fetzima",
"NonProprietaryName": "Levomilnacipran Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130725",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204168",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LEVOMILNACIPRAN HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130725",
"SamplePackage": "Y",
"IndicationAndUsage": "FETZIMA® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.",
"Description": "FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only)."
},
{
"NDCCode": "0536-2220-75",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0536-2220-75) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00536-2220-75",
"ProductNDC": "0536-2220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"EndMarketingDate": "20220801",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170301",
"EndMarketingDatePackage": "20220801",
"SamplePackage": "N"
},
{
"NDCCode": "36987-2220-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2220-3)",
"NDC11Code": "36987-2220-03",
"ProductNDC": "36987-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flaxseed",
"NonProprietaryName": "Flaxseed",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "43742-2220-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-2220-1) ",
"NDC11Code": "43742-2220-01",
"ProductNDC": "43742-2220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Focus",
"NonProprietaryName": "Adenosinum Cyclophosphoricum, Adrenalinum, Aethusa Cynapium, Alpha-ketoglutaricum Acidum, Ambra Grisea, Baryta Carbonica, Candida Albicans, Carboneum Sulphuratum, Cerebrum Suis, Ginkgo Biloba, Helleborus Niger, Hypothalamus Suis, Hyoscyamus Niger, Iodium, Phosphorus, Saccharum Officinale, Sarcolacticum Acid, Silicea, Tarentula Hispana, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20241113",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; AETHUSA CYNAPIUM WHOLE; OXOGLURIC ACID; AMBERGRIS; BARIUM CARBONATE; CANDIDA ALBICANS; CARBON DISULFIDE; SUS SCROFA CEREBRUM; GINKGO; HELLEBORUS NIGER ROOT; SUS SCROFA HYPOTHALAMUS; HYOSCYAMUS NIGER; IODINE; PHOSPHORUS; SUCROSE; LACTIC ACID, L-; SILICON DIOXIDE; LYCOSA TARANTULA; VERATRUM ALBUM ROOT",
"StrengthNumber": "8; 8; 12; 6; 9; 12; 12; 9; 8; 3; 12; 8; 12; 6; 6; 6; 6; 8; 16; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241113",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of symptoms including. poor attention excessive movement difficult concentrating. quick temper restlessness sensitivity to noise forgetfulness. easy boredom mood changes impulsivity temper tantrums. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "50090-2220-0",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2220-0)",
"NDC11Code": "50090-2220-00",
"ProductNDC": "50090-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glipizide",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Glipizide",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20150702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076467",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "GLIPIZIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "67296-2220-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (67296-2220-3) ",
"NDC11Code": "67296-2220-03",
"ProductNDC": "67296-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202433",
"LabelerName": "Redpharm Drug",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N",
"IndicationAndUsage": "Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.",
"Description": "Tamsulosin hydrochloride is an antagonist of alpha 1Aadrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride USP is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C 20H 28N 2O 5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is: Each tamsulosin hydrochloride capsule, USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: calcium stearate, FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer dispersion, sodium lauryl sulfate, talc, triacetin, and titanium dioxide. The capsules are printed with SW-9008 Black Ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Meets USP dissolution test 10."
},
{
"NDCCode": "68071-2220-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-2220-3) ",
"NDC11Code": "68071-2220-03",
"ProductNDC": "68071-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19931001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074342",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200721",
"SamplePackage": "N",
"IndicationAndUsage": "Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake."
},
{
"NDCCode": "71335-2220-1",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (71335-2220-1) ",
"NDC11Code": "71335-2220-01",
"ProductNDC": "71335-2220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205129",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230815",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake."
},
{
"NDCCode": "82969-2220-1",
"PackageDescription": "30 [hp_C] in 1 BOTTLE, GLASS (82969-2220-1) ",
"NDC11Code": "82969-2220-01",
"ProductNDC": "82969-2220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bestmade Natural Products Bm220",
"NonProprietaryName": "China Off, Colocynthis, Dulcamara, Merc Dul, Podophyllum, Baptisia, Chamomilla",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Bestmade Natural Products",
"SubstanceName": "PODOPHYLLUM; CHAMOMILE; SOLANUM DULCAMARA FLOWER; BAPTISIA AUSTRALIS ROOT; CINCHONA OFFICINALIS BARK; CALOMEL; CITRULLUS COLOCYNTHIS FRUIT PULP",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Use: Temporarily relieves discomfort due to digestive issues, including discomfort in the lower part of the colon that spreads upwards, cramping aches in the abdomen, and bloody mucus in stools.*."
},
{
"NDCCode": "85816-2220-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (85816-2220-1) ",
"NDC11Code": "85816-2220-01",
"ProductNDC": "85816-2220",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bm Bm220 Drops",
"NonProprietaryName": "Baptisia, Chamomilla, China Off, Colocynthis, Dulcamara, Merc Dul, Podophyllum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BM Private Limited",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; CHAMOMILE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA TOP; CALOMEL; PODOPHYLLUM",
"StrengthNumber": "7; 7; 7; 8; 7; 10; 7",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: For detail please read the enclosed package (Product information leaflet)."
},
{
"NDCCode": "0456-0095-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0456-0095-30)",
"NDC11Code": "00456-0095-30",
"ProductNDC": "0456-0095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daliresp",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022522",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-0800-30",
"PackageDescription": "1 POUCH in 1 CARTON (0456-0800-30) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER",
"NDC11Code": "00456-0800-30",
"ProductNDC": "0456-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-0800-31",
"PackageDescription": "1 POUCH in 1 CARTON (0456-0800-31) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER",
"NDC11Code": "00456-0800-31",
"ProductNDC": "0456-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-1101-30",
"PackageDescription": "1 KIT in 1 BLISTER PACK (0456-1101-30) ",
"NDC11Code": "00456-1101-30",
"ProductNDC": "0456-1101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N"
},
{
"NDCCode": "0456-1110-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1110-30) ",
"NDC11Code": "00456-1110-30",
"ProductNDC": "0456-1110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N",
"IndicationAndUsage": "VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only)."
},
{
"NDCCode": "0456-1120-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1120-30) ",
"NDC11Code": "00456-1120-30",
"ProductNDC": "0456-1120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N",
"IndicationAndUsage": "VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only)."
},
{
"NDCCode": "0456-1140-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1140-30) ",
"NDC11Code": "00456-1140-30",
"ProductNDC": "0456-1140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N",
"IndicationAndUsage": "VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only)."
},
{
"NDCCode": "0456-1201-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1201-30",
"ProductNDC": "0456-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "145",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120908",
"SamplePackage": "N",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1202-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1202-30",
"ProductNDC": "0456-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "290",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120908",
"SamplePackage": "N",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1203-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1203-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1203-30",
"ProductNDC": "0456-1203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "72",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1207-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1207-30) ",
"NDC11Code": "00456-1207-30",
"ProductNDC": "0456-1207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "7; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160718",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1214-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1214-30) ",
"NDC11Code": "00456-1214-30",
"ProductNDC": "0456-1214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "14; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141224",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1221-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1221-30) ",
"NDC11Code": "00456-1221-30",
"ProductNDC": "0456-1221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "21; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160718",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
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"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
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"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
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{
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"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1402-30) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
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"LabelerName": "Allergan, Inc.",
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"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1405-30",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Allergan, Inc.",
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"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1410-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1410-30) ",
"NDC11Code": "00456-1410-30",
"ProductNDC": "0456-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"LabelerName": "Allergan, Inc.",
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"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
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"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1420-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1420-30) ",
"NDC11Code": "00456-1420-30",
"ProductNDC": "0456-1420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
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"DosageFormName": "TABLET",
"RouteName": "ORAL",
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"LabelerName": "Allergan, Inc.",
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"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
}
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<Description>FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only).</Description>
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<Description>FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only).</Description>
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<Description>FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only).</Description>
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<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>43742-2220-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-2220-1) </PackageDescription>
<NDC11Code>43742-2220-01</NDC11Code>
<ProductNDC>43742-2220</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Focus</ProprietaryName>
<NonProprietaryName>Adenosinum Cyclophosphoricum, Adrenalinum, Aethusa Cynapium, Alpha-ketoglutaricum Acidum, Ambra Grisea, Baryta Carbonica, Candida Albicans, Carboneum Sulphuratum, Cerebrum Suis, Ginkgo Biloba, Helleborus Niger, Hypothalamus Suis, Hyoscyamus Niger, Iodium, Phosphorus, Saccharum Officinale, Sarcolacticum Acid, Silicea, Tarentula Hispana, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241113</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; EPINEPHRINE; AETHUSA CYNAPIUM WHOLE; OXOGLURIC ACID; AMBERGRIS; BARIUM CARBONATE; CANDIDA ALBICANS; CARBON DISULFIDE; SUS SCROFA CEREBRUM; GINKGO; HELLEBORUS NIGER ROOT; SUS SCROFA HYPOTHALAMUS; HYOSCYAMUS NIGER; IODINE; PHOSPHORUS; SUCROSE; LACTIC ACID, L-; SILICON DIOXIDE; LYCOSA TARANTULA; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>8; 8; 12; 6; 9; 12; 12; 9; 8; 3; 12; 8; 12; 6; 6; 6; 6; 8; 16; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the temporary relief of symptoms including. poor attention excessive movement difficult concentrating. quick temper restlessness sensitivity to noise forgetfulness. easy boredom mood changes impulsivity temper tantrums. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-2220-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2220-0)</PackageDescription>
<NDC11Code>50090-2220-00</NDC11Code>
<ProductNDC>50090-2220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glipizide</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Glipizide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076467</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>GLIPIZIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sulfonylurea [EPC],Sulfonylurea Compounds [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67296-2220-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (67296-2220-3) </PackageDescription>
<NDC11Code>67296-2220-03</NDC11Code>
<ProductNDC>67296-2220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamsulosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Tamsulosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202433</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.</IndicationAndUsage>
<Description>Tamsulosin hydrochloride is an antagonist of alpha 1Aadrenoceptors in the prostate. Tamsulosin hydrochloride is (-)-( R)-5-[2-[[2-( o-Ethoxyphenoxy) ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride. Tamsulosin hydrochloride USP is a white or almost white crystalline powder that melts with decomposition at approximately 230°C. It is sparingly soluble in water and methanol, slightly soluble in glacial acetic acid and ethanol, and practically insoluble in ether. The molecular formula of tamsulosin hydrochloride is C 20H 28N 2O 5S HCl. The molecular weight of tamsulosin hydrochloride is 444.98. Its structural formula is: Each tamsulosin hydrochloride capsule, USP for oral administration contains tamsulosin hydrochloride USP 0.4 mg, and the following inactive ingredients: calcium stearate, FD&C Blue 2, gelatin, iron oxide red, iron oxide yellow, microcrystalline cellulose, methacrylic acid and ethyl acrylate copolymer dispersion, sodium lauryl sulfate, talc, triacetin, and titanium dioxide. The capsules are printed with SW-9008 Black Ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Meets USP dissolution test 10.</Description>
</NDC>
<NDC>
<NDCCode>68071-2220-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (68071-2220-3) </PackageDescription>
<NDC11Code>68071-2220-03</NDC11Code>
<ProductNDC>68071-2220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074342</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Anxiety Disorders. Alprazolam tablets, USP are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or 'mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to alprazolam. Panic Disorder. Alprazolam tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Alprazolam tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its structural formula is. Alprazolam, USP is a white to off-white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>71335-2220-1</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (71335-2220-1) </PackageDescription>
<NDC11Code>71335-2220-01</NDC11Code>
<ProductNDC>71335-2220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205129</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate and titanium dioxide. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol, sodium hydroxide, titanium dioxide, povidone and FD&C Red #40 aluminum lake. 100 mg capsule contains shellac, propylene glycol, ammonia and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol, ammonia and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, ammonia, yellow iron oxide, and FD & C Blue No. # 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>82969-2220-1</NDCCode>
<PackageDescription>30 [hp_C] in 1 BOTTLE, GLASS (82969-2220-1) </PackageDescription>
<NDC11Code>82969-2220-01</NDC11Code>
<ProductNDC>82969-2220</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bestmade Natural Products Bm220</ProprietaryName>
<NonProprietaryName>China Off, Colocynthis, Dulcamara, Merc Dul, Podophyllum, Baptisia, Chamomilla</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Bestmade Natural Products</LabelerName>
<SubstanceName>PODOPHYLLUM; CHAMOMILE; SOLANUM DULCAMARA FLOWER; BAPTISIA AUSTRALIS ROOT; CINCHONA OFFICINALIS BARK; CALOMEL; CITRULLUS COLOCYNTHIS FRUIT PULP</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]; [hp_C]/30[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use: Temporarily relieves discomfort due to digestive issues, including discomfort in the lower part of the colon that spreads upwards, cramping aches in the abdomen, and bloody mucus in stools.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85816-2220-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (85816-2220-1) </PackageDescription>
<NDC11Code>85816-2220-01</NDC11Code>
<ProductNDC>85816-2220</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bm Bm220 Drops</ProprietaryName>
<NonProprietaryName>Baptisia, Chamomilla, China Off, Colocynthis, Dulcamara, Merc Dul, Podophyllum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BM Private Limited</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; CHAMOMILE; CINCHONA OFFICINALIS BARK; CITRULLUS COLOCYNTHIS FRUIT PULP; SOLANUM DULCAMARA TOP; CALOMEL; PODOPHYLLUM</SubstanceName>
<StrengthNumber>7; 7; 7; 8; 7; 10; 7</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: For detail please read the enclosed package (Product information leaflet).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0456-0095-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0456-0095-30)</PackageDescription>
<NDC11Code>00456-0095-30</NDC11Code>
<ProductNDC>0456-0095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daliresp</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022522</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0456-0800-30</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0456-0800-30) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>00456-0800-30</NDC11Code>
<ProductNDC>0456-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0456-0800-31</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0456-0800-31) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>00456-0800-31</NDC11Code>
<ProductNDC>0456-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0456-1101-30</NDCCode>
<PackageDescription>1 KIT in 1 BLISTER PACK (0456-1101-30) </PackageDescription>
<NDC11Code>00456-1101-30</NDC11Code>
<ProductNDC>0456-1101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0456-1110-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1110-30) </PackageDescription>
<NDC11Code>00456-1110-30</NDC11Code>
<ProductNDC>0456-1110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).</Description>
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<NDC>
<NDCCode>0456-1120-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1120-30) </PackageDescription>
<NDC11Code>00456-1120-30</NDC11Code>
<ProductNDC>0456-1120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0456-1140-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1140-30) </PackageDescription>
<NDC11Code>00456-1140-30</NDC11Code>
<ProductNDC>0456-1140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0456-1201-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1201-30</NDC11Code>
<ProductNDC>0456-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1202-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1202-30</NDC11Code>
<ProductNDC>0456-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>290</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1203-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1203-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1203-30</NDC11Code>
<ProductNDC>0456-1203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1207-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1207-30) </PackageDescription>
<NDC11Code>00456-1207-30</NDC11Code>
<ProductNDC>0456-1207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1214-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1214-30) </PackageDescription>
<NDC11Code>00456-1214-30</NDC11Code>
<ProductNDC>0456-1214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1221-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1221-30) </PackageDescription>
<NDC11Code>00456-1221-30</NDC11Code>
<ProductNDC>0456-1221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>21; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1228-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1228-30) </PackageDescription>
<NDC11Code>00456-1228-30</NDC11Code>
<ProductNDC>0456-1228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1402-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1402-30) </PackageDescription>
<NDC11Code>00456-1402-30</NDC11Code>
<ProductNDC>0456-1402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1405-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1405-30) </PackageDescription>
<NDC11Code>00456-1405-30</NDC11Code>
<ProductNDC>0456-1405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1410-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1410-30) </PackageDescription>
<NDC11Code>00456-1410-30</NDC11Code>
<ProductNDC>0456-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1420-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1420-30) </PackageDescription>
<NDC11Code>00456-1420-30</NDC11Code>
<ProductNDC>0456-1420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
</NDCList>