{
"NDC": [
{
"NDCCode": "0002-4463-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0002-4463-30) ",
"NDC11Code": "00002-4463-30",
"ProductNDC": "0002-4463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20031126",
"SamplePackage": "N",
"IndicationAndUsage": "CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as almond-shaped tablets for oral administration. Each tablet contains 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "0002-4463-01",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0002-4463-01) > 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00002-4463-01",
"ProductNDC": "0002-4463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-03-31"
},
{
"NDCCode": "0002-4463-63",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0002-4463-63) > 3 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00002-4463-63",
"ProductNDC": "0002-4463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-02-06"
},
{
"NDCCode": "50436-4463-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50436-4463-1) ",
"NDC11Code": "50436-4463-01",
"ProductNDC": "50436-4463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cialis",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20031126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021368",
"LabelerName": "Unit Dose Services",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190221",
"SamplePackage": "N",
"IndicationAndUsage": "CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "68071-4463-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68071-4463-3) ",
"NDC11Code": "68071-4463-03",
"ProductNDC": "68071-4463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091283",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180604",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. ( 1).",
"Description": "Tizanidine hydrochloride is a central alpha 2-adrenergic agonist. Tizanidine HCl is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine's molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose and anhydrous lactose."
},
{
"NDCCode": "70518-4463-1",
"PackageDescription": "30 CAPSULE in 1 BLISTER PACK (70518-4463-1) ",
"NDC11Code": "70518-4463-01",
"ProductNDC": "70518-4463",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Pamoate",
"NonProprietaryName": "Hydroxyzine Pamoate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250830",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201507",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "HYDROXYZINE PAMOATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250911",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) and can be structurally represented as follows:. Chemical Formula: C 21H 27ClN 2O 2.C 23H 16O 6. Molecular Weight: 763.29. Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, D&C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate."
},
{
"NDCCode": "53499-4463-4",
"PackageDescription": "3 BOTTLE, PLASTIC in 1 CARTON (53499-4463-4) / 120 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "53499-4463-04",
"ProductNDC": "53499-4463",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold Relief Alcohol Free Cherry Syrup",
"NonProprietaryName": "Pelargonium Sidoides",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20230522",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Schwabe North America, Inc",
"SubstanceName": "PELARGONIUM SIDOIDES ROOT",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/120mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230522",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat."
},
{
"NDCCode": "0002-0872-30",
"PackageDescription": "30 TRAY in 1 BOX (0002-0872-30) > 330 CARTRIDGE in 1 TRAY > 3 mL in 1 CARTRIDGE",
"NDC11Code": "00002-0872-30",
"ProductNDC": "0002-0872",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Insulin Lispro-aabc",
"DosageFormName": "INJECTION, SOLUTION",
"StartMarketingDate": "20200615",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Status": "Unfinished",
"LastUpdate": "2022-03-16",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "31-DEC-20"
},
{
"NDCCode": "0002-1200-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-1200-30",
"ProductNDC": "0002-1200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amyvid",
"NonProprietaryName": "Florbetapir F 18",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202008",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "FLORBETAPIR F-18",
"StrengthNumber": "51",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120601",
"SamplePackage": "N"
},
{
"NDCCode": "0002-1210-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1210-30) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-1210-30",
"ProductNDC": "0002-1210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tauvid",
"NonProprietaryName": "Flortaucipir F-18",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200528",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212123",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "FLORTAUCIPIR F-18",
"StrengthNumber": "51",
"StrengthUnit": "mCi/mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200528",
"SamplePackage": "N"
},
{
"NDCCode": "0002-3227-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3227-30) ",
"NDC11Code": "00002-3227-30",
"ProductNDC": "0002-3227",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3228-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3228-30) ",
"NDC11Code": "00002-3228-30",
"ProductNDC": "0002-3228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3229-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3229-30) ",
"NDC11Code": "00002-3229-30",
"ProductNDC": "0002-3229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3230-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3230-30) ",
"NDC11Code": "00002-3230-30",
"ProductNDC": "0002-3230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbyax",
"NonProprietaryName": "Olanzapine And Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070409",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021520",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE; OLANZAPINE",
"StrengthNumber": "25; 3",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070409",
"SamplePackage": "N",
"IndicationAndUsage": "SYMBYAX® is indicated for the treatment of: : 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)]. .",
"Description": "SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. SYMBYAX capsules are available for oral administration in the following strength combinations. Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide."
},
{
"NDCCode": "0002-3231-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3231-30) ",
"NDC11Code": "00002-3231-30",
"ProductNDC": "0002-3231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbyax",
"NonProprietaryName": "Olanzapine And Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20031224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021520",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE; OLANZAPINE",
"StrengthNumber": "25; 6",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20040119",
"SamplePackage": "N",
"IndicationAndUsage": "SYMBYAX® is indicated for the treatment of: : 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)]. .",
"Description": "SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. SYMBYAX capsules are available for oral administration in the following strength combinations. Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide."
},
{
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"ProductNDC": "0002-3232",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbyax",
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"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3233-30) ",
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"ProductNDC": "0002-3233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbyax",
"NonProprietaryName": "Olanzapine And Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20031224",
"EndMarketingDate": "20210430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021520",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
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"NDC11Code": "00002-3234-30",
"ProductNDC": "0002-3234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Symbyax",
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"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20031224",
"EndMarketingDate": "20210426",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021520",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE; FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "12; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
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{
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"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3238-30) ",
"NDC11Code": "00002-3238-30",
"ProductNDC": "0002-3238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3239-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3239-30) ",
"NDC11Code": "00002-3239-30",
"ProductNDC": "0002-3239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20021126",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030110",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3240-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3240-30) ",
"NDC11Code": "00002-3240-30",
"ProductNDC": "0002-3240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"EndMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20040824",
"EndMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "CYMBALTA® is indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .",
"Description": "CYMBALTA® (duloxetine delayed-release capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "0002-3250-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3250-30) ",
"NDC11Code": "00002-3250-30",
"ProductNDC": "0002-3250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050214",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3251-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0002-3251-30) ",
"NDC11Code": "00002-3251-30",
"ProductNDC": "0002-3251",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20050214",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050824",
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"SamplePackage": "N",
"IndicationAndUsage": "STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.",
"Description": "Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink."
},
{
"NDCCode": "0002-3270-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0002-3270-30) ",
"NDC11Code": "00002-3270-30",
"ProductNDC": "0002-3270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100115",
"EndMarketingDate": "20261002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100115",
"EndMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "CYMBALTA® is indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older , 5 Chronic musculoskeletal pain in adults .",
"Description": "CYMBALTA® (duloxetine delayed-release capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow."
},
{
"NDCCode": "0002-4112-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0002-4112-30) ",
"NDC11Code": "00002-4112-30",
"ProductNDC": "0002-4112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyprexa",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970623",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020592",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970623",
"SamplePackage": "N",
"IndicationAndUsage": "ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
},
{
"NDCCode": "0002-4115-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0002-4115-30) ",
"NDC11Code": "00002-4115-30",
"ProductNDC": "0002-4115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zyprexa",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020592",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
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"IndicationAndUsage": "ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
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"Description": "ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
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"IndicationAndUsage": "ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH."
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"LabelerName": "Eli Lilly and Company",
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"LabelerName": "Eli Lilly and Company",
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"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
}
]
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<Description>CIALIS (tadalafil) is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. CIALIS is available as almond-shaped tablets for oral administration. Each tablet contains 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
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<IndicationAndUsage>Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. ( 1).</IndicationAndUsage>
<Description>Tizanidine hydrochloride is a central alpha 2-adrenergic agonist. Tizanidine HCl is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. Tizanidine's molecular formula is C 9H 8ClN 5S-HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets contain the active ingredient, tizanidine hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, colloidal silicon dioxide, stearic acid, microcrystalline cellulose and anhydrous lactose.</Description>
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<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine pamoate is a light yellow odorless powder, practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-( p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4 -methylenebis[3-hydroxy-2-naphthoate] (1:1) and can be structurally represented as follows:. Chemical Formula: C 21H 27ClN 2O 2.C 23H 16O 6. Molecular Weight: 763.29. Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, D&C Yellow #10), printing ink which contains shellac glaze ~45% (20% esterified) in Ethanol, iron oxide black, n-butyl alcohol, isopropyl alcohol, propylene glycol and ammonium hydroxide 28%); magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>53499-4463-4</NDCCode>
<PackageDescription>3 BOTTLE, PLASTIC in 1 CARTON (53499-4463-4) / 120 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>53499-4463-04</NDC11Code>
<ProductNDC>53499-4463</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold Relief Alcohol Free Cherry Syrup</ProprietaryName>
<NonProprietaryName>Pelargonium Sidoides</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230522</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Schwabe North America, Inc</LabelerName>
<SubstanceName>PELARGONIUM SIDOIDES ROOT</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/120mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230522</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial irritations: congestion, cough, hoarseness, sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0002-0872-30</NDCCode>
<PackageDescription>30 TRAY in 1 BOX (0002-0872-30) > 330 CARTRIDGE in 1 TRAY > 3 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00002-0872-30</NDC11Code>
<ProductNDC>0002-0872</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Insulin Lispro-aabc</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20200615</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-03-16</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-DEC-20</StartMarketingDatePackage>
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<NDC>
<NDCCode>0002-1200-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-30) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-1200-30</NDC11Code>
<ProductNDC>0002-1200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amyvid</ProprietaryName>
<NonProprietaryName>Florbetapir F 18</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202008</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>FLORBETAPIR F-18</SubstanceName>
<StrengthNumber>51</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0002-1210-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1210-30) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-1210-30</NDC11Code>
<ProductNDC>0002-1210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tauvid</ProprietaryName>
<NonProprietaryName>Flortaucipir F-18</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200528</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212123</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>FLORTAUCIPIR F-18</SubstanceName>
<StrengthNumber>51</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0002-3227-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3227-30) </PackageDescription>
<NDC11Code>00002-3227-30</NDC11Code>
<ProductNDC>0002-3227</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3228-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3228-30) </PackageDescription>
<NDC11Code>00002-3228-30</NDC11Code>
<ProductNDC>0002-3228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3229-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3229-30) </PackageDescription>
<NDC11Code>00002-3229-30</NDC11Code>
<ProductNDC>0002-3229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021126</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030110</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD.</IndicationAndUsage>
<Description>Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R(-) isomer as determined by x-ray diffraction and its chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride and its molecular formula is C17H21NOHCl, which corresponds to a molecular weight of 291.82. The chemical structure is:. Atomoxetine hydrochloride is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. STRATTERA (atomoxetine) capsules are for oral administration only. Each STRATTERA capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine (equivalent to 11.4 mg, 20.6 mg, 28.6 mg, 45.7 mg, 68.6 mg, 91.4 mg and 114.3 mg of atomoxetine hydrochloride, respectively). The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and one or more of the following inactive ingredients:. FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.</Description>
</NDC>
<NDC>
<NDCCode>0002-3230-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3230-30) </PackageDescription>
<NDC11Code>00002-3230-30</NDC11Code>
<ProductNDC>0002-3230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbyax</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070409</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021520</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE; OLANZAPINE</SubstanceName>
<StrengthNumber>25; 3</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMBYAX® is indicated for the treatment of: : 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. SYMBYAX capsules are available for oral administration in the following strength combinations. Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0002-3231-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3231-30) </PackageDescription>
<NDC11Code>00002-3231-30</NDC11Code>
<ProductNDC>0002-3231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbyax</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021520</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE; OLANZAPINE</SubstanceName>
<StrengthNumber>25; 6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SYMBYAX® is indicated for the treatment of: : 1 Acute depressive episodes in Bipolar I Disorder [see Clinical Studies (14.1)]. , 2 Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)]. .</IndicationAndUsage>
<Description>SYMBYAX (olanzapine and fluoxetine HCl capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac and Sarafem). Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride. The molecular formula is C17H18F3NOHCl, which corresponds to a molecular weight of 345.79. The chemical structures are. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. SYMBYAX capsules are available for oral administration in the following strength combinations. Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0002-3232-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3232-30) </PackageDescription>
<NDC11Code>00002-3232-30</NDC11Code>
<ProductNDC>0002-3232</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbyax</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031224</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021520</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040119</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0002-3233-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3233-30) </PackageDescription>
<NDC11Code>00002-3233-30</NDC11Code>
<ProductNDC>0002-3233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbyax</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031224</StartMarketingDate>
<EndMarketingDate>20210430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021520</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040119</StartMarketingDatePackage>
<EndMarketingDatePackage>20210430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0002-3234-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0002-3234-30) </PackageDescription>
<NDC11Code>00002-3234-30</NDC11Code>
<ProductNDC>0002-3234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Symbyax</ProprietaryName>
<NonProprietaryName>Olanzapine And Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031224</StartMarketingDate>
<EndMarketingDate>20210426</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021520</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE; FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20040119</StartMarketingDatePackage>
<EndMarketingDatePackage>20210426</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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<Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
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<Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
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<IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0002-4117-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0002-4117-30) </PackageDescription>
<NDC11Code>00002-4117-30</NDC11Code>
<ProductNDC>0002-4117</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zyprexa</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961001</StartMarketingDate>
<EndMarketingDate>20260524</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020592</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19961001</StartMarketingDatePackage>
<EndMarketingDatePackage>20260524</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) , 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine is a yellow crystalline solid, which is practically insoluble in water. ZYPREXA tablets are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are carnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg). The 2.5, 5, 7.5, and 10 mg tablets are imprinted with edible ink which contains FD&C Blue No. 2 Aluminum Lake. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) is intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. ZYPREXA ZYDIS (olanzapine orally disintegrating tablets) also contains the following inactive ingredients: gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propyl paraben. ZYPREXA IntraMuscular (olanzapine for injection) is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0002-4165-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0002-4165-30)</PackageDescription>
<NDC11Code>00002-4165-30</NDC11Code>
<ProductNDC>0002-4165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Evista</ProprietaryName>
<NonProprietaryName>Raloxifene Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020815</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>RALOXIFENE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-23</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0002-4178-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4178-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4178-01) </PackageDescription>
<NDC11Code>00002-4178-31</NDC11Code>
<ProductNDC>0002-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
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