{
"NDC": [
{
"NDCCode": "21695-146-15",
"PackageDescription": "15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-146-15)",
"NDC11Code": "21695-0146-15",
"ProductNDC": "21695-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1)Efficacy was established in 4 short-term and one maintenance trial in adults (14.1)., 2 Generalized Anxiety Disorder (GAD) (1.2)Efficacy was established in 3 short-term and one maintenance trial in adults (14.2)., 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1.3), 4 Fibromyalgia (FM) (1.4).",
"Description": "Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) 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 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, 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": "21695-146-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-146-30)",
"NDC11Code": "21695-0146-30",
"ProductNDC": "21695-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1)Efficacy was established in 4 short-term and one maintenance trial in adults (14.1)., 2 Generalized Anxiety Disorder (GAD) (1.2)Efficacy was established in 3 short-term and one maintenance trial in adults (14.2)., 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1.3), 4 Fibromyalgia (FM) (1.4).",
"Description": "Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) 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 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, 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": "10135-146-14",
"PackageDescription": "15 g in 1 BOTTLE, PLASTIC (10135-146-14) ",
"NDC11Code": "10135-0146-14",
"ProductNDC": "10135-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Polystyrene Sulfonate",
"NonProprietaryName": "Sodium Polystyrene Sulfonate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204071",
"LabelerName": "Marlex Pharmaceuticals Inc",
"SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
"StrengthNumber": "4.1",
"StrengthUnit": "meq/g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.",
"Description": "Sodium polystyrene sulfonate is a benzene, diethenyl- polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a golden brown finely ground, powdered form of sodium polystyrene sulfonate, a cation exchange resin prepared in the sodium phase with an in vitroexchange capacity of approximately 3.1 mEq ( in vivoapproximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema."
},
{
"NDCCode": "16590-146-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (16590-146-15)",
"NDC11Code": "16590-0146-15",
"ProductNDC": "16590-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meclizine Hydrochloride",
"NonProprietaryName": "Meclizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19810603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087128",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC],Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.",
"Description": "Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:. C25H27CIN22HCIH2O M.W. 481.89. The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration. *Contains FD&C Yellow #5 (see PRECAUTIONS). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5."
},
{
"NDCCode": "20276-146-15",
"PackageDescription": "444 mL in 1 BOTTLE, PLASTIC (20276-146-15) ",
"NDC11Code": "20276-0146-15",
"ProductNDC": "20276-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lucky",
"ProprietaryNameSuffix": "Antibacterial",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Delta Brands, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201104",
"SamplePackage": "N",
"IndicationAndUsage": "for hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "24909-146-15",
"PackageDescription": "14 g in 1 TUBE (24909-146-15) ",
"NDC11Code": "24909-0146-15",
"ProductNDC": "24909-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Ipl Relief",
"NonProprietaryName": "Thuja Occidentalis",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140314",
"EndMarketingDate": "20250315",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181229",
"EndMarketingDatePackage": "20250315",
"SamplePackage": "N",
"IndicationAndUsage": "Relief from symptoms of itch, papules (bumps) and lesions often associated with Molluscum per diagnosis and care by physician."
},
{
"NDCCode": "46144-146-01",
"PackageDescription": "15 PATCH in 1 BOX (46144-146-01) > 100 g in 1 PATCH",
"NDC11Code": "46144-0146-01",
"ProductNDC": "46144-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solaice",
"NonProprietaryName": "Menthol,capsaicin",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "API Solutions, Inc.",
"SubstanceName": "CAPSAICIN; MENTHOL",
"StrengthNumber": ".05; 5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2015-07-28"
},
{
"NDCCode": "53329-146-15",
"PackageDescription": "198 g in 1 TUBE (53329-146-15) ",
"NDC11Code": "53329-0146-15",
"ProductNDC": "53329-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medline",
"NonProprietaryName": "White Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230301",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "WHITE PETROLATUM",
"StrengthNumber": "983",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230601",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N"
},
{
"NDCCode": "64220-146-03",
"PackageDescription": "15 kg in 1 CANISTER (64220-146-03) ",
"NDC11Code": "64220-0146-03",
"ProductNDC": "64220-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240604",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-06-05",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-JUN-24"
},
{
"NDCCode": "64220-146-06",
"PackageDescription": "15 kg in 1 DRUM (64220-146-06) ",
"NDC11Code": "64220-0146-06",
"ProductNDC": "64220-146",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketotifen Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240604",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "KETOTIFEN FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-06-05",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "04-JUN-24"
},
{
"NDCCode": "66259-936-15",
"PackageDescription": "1 KIT in 1 KIT (66259-936-15) * 10 mL in 1 VIAL, PLASTIC * 1 VIAL in 1 VIAL (66259-146-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01) ",
"NDC11Code": "66259-0936-15",
"ProductNDC": "66259-936",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spy-mis Kit",
"NonProprietaryName": "Indocyanine Green",
"DosageFormName": "KIT",
"RouteName": "INTRADERMAL; INTRAVASCULAR; INTRAVENOUS",
"StartMarketingDate": "20190910",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211580",
"LabelerName": "Novadaq Technologies Inc",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190910",
"SamplePackage": "N",
"IndicationAndUsage": "SPY AGENT GREEN is an optical imaging agent indicated for use with a fluorescence imaging device for: : 1 Visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries including general minimally invasive surgical procedures in adults and pediatric patients one month of age and older. (1.1) , 2 Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older. (1.2) , 3 Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer. (1.3) , 4 Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with breast cancer. (1.4).",
"Description": "SPY AGENT GREEN (indocyanine green for injection, USP) is a water soluble, optical imaging agent which is reconstituted with Sterile Water for Injection, USP, for intravenous, interstitial or intradermal use. Each vial contains a sterile, lyophilized, green powder containing 25 mg of indocyanine green with not more than 5% sodium iodide. Hydrochloric acid or sodium hydroxide may be used to adjust the pH prior to lyophilization. The chemical name for Indocyanine Green is 1 HBenz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. Molecular Formula: C 43H 47N 2NaO 6S 2; Molecular Mass: 774.96 g/mol, with the following structural formula:. Indocyanine green has a peak spectral absorption at 805 nm. SPY AGENT GREEN has a pH of 5.5 to 7.5 when reconstituted with Sterile Water for Injection, USP."
},
{
"NDCCode": "67046-146-15",
"PackageDescription": "15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-146-15)",
"NDC11Code": "67046-0146-15",
"ProductNDC": "67046-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090070",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"Description": "Divalproex sodium USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium USP has the following structure:. Divalproex sodium USP occurs as a white to off white powder with a characteristic odor, very soluble in chloroform, freely soluble in methanol and ethyl ether, soluble in acetone, practically insoluble in acetonitrile. Divalproex sodium extended-release tablets USP, 500 mg are for oral administration. Divalproex sodium extended-release tablets USP, contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release tablets USP, 500 mg: Hydroxy ethyl cellulose, hydroxy propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, silicon dioxide, and titanium dioxide. Divalproex sodium extended-release tablets meets USP Dissolution Test 5."
},
{
"NDCCode": "70700-146-15",
"PackageDescription": "1 TUBE in 1 CARTON (70700-146-15) / 15 g in 1 TUBE",
"NDC11Code": "70700-0146-15",
"ProductNDC": "70700-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212976",
"LabelerName": "Xiromed LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191209",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Ointment, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Ointment contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, white petrolatum, propylene carbonate, propylene glycol and white wax. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "71919-146-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-146-07) ",
"NDC11Code": "71919-0146-07",
"ProductNDC": "71919-146",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Fluorica",
"NonProprietaryName": "Calcium Fluoride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CALCIUM FLUORIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "21695-002-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (21695-002-15)",
"NDC11Code": "21695-0002-15",
"ProductNDC": "21695-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ABILIFY is an atypical antipsychotic indicated as oral formulations for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1), 2 Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1).",
"Description": "Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection."
},
{
"NDCCode": "21695-003-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (21695-003-15)",
"NDC11Code": "21695-0003-15",
"ProductNDC": "21695-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ABILIFY is an atypical antipsychotic indicated as oral formulations for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1), 2 Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1).",
"Description": "Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection."
},
{
"NDCCode": "21695-004-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (21695-004-15)",
"NDC11Code": "21695-0004-15",
"ProductNDC": "21695-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abilify",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021436",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ABILIFY is an atypical antipsychotic indicated as oral formulations for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1), 2 Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1).",
"Description": "Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection."
},
{
"NDCCode": "21695-008-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (21695-008-15)",
"NDC11Code": "21695-0008-15",
"ProductNDC": "21695-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Use for temporary relief of minor aches and pains due to. ° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever."
},
{
"NDCCode": "21695-022-15",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (21695-022-15)",
"NDC11Code": "21695-0022-15",
"ProductNDC": "21695-022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "21695-023-15",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (21695-023-15)",
"NDC11Code": "21695-0023-15",
"ProductNDC": "21695-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celebrex",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19981002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020998",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate."
},
{
"NDCCode": "21695-035-15",
"PackageDescription": "1 TUBE in 1 CARTON (21695-035-15) > 15 g in 1 TUBE",
"NDC11Code": "21695-0035-15",
"ProductNDC": "21695-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19950601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). for effective relief of. itching. scaling. cracking. burning. redness. soreness. irritation. discomfort."
},
{
"NDCCode": "21695-037-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (21695-037-15)",
"NDC11Code": "21695-0037-15",
"ProductNDC": "21695-037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078218",
"LabelerName": "Rebel Distributors",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets 10 mg contain the following inactive ingredients: croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide."
},
{
"NDCCode": "21695-045-15",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-045-15)",
"NDC11Code": "21695-0045-15",
"ProductNDC": "21695-045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr Extended-release",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "21695-046-15",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-046-15)",
"NDC11Code": "21695-0046-15",
"ProductNDC": "21695-046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr Extended-release",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "21695-047-15",
"PackageDescription": "15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-047-15)",
"NDC11Code": "21695-0047-15",
"ProductNDC": "21695-047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr Extended-release",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "21695-060-15",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (21695-060-15)",
"NDC11Code": "21695-0060-15",
"ProductNDC": "21695-060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].",
"Description": "GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON Capsules contain ziprasidone hydrochloride monohydrate, lactose, pregelatinized starch, and magnesium stearate. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS CH3SO3H 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [See Dosage and Administration (2.3)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "21695-061-15",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (21695-061-15)",
"NDC11Code": "21695-0061-15",
"ProductNDC": "21695-061",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Geodon",
"NonProprietaryName": "Ziprasidone Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20010205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020825",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].",
"Description": "GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON Capsules contain ziprasidone hydrochloride monohydrate, lactose, pregelatinized starch, and magnesium stearate. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS CH3SO3H 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [See Dosage and Administration (2.3)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
},
{
"NDCCode": "21695-070-15",
"PackageDescription": "15 TABLET in 1 DRUM (21695-070-15)",
"NDC11Code": "21695-0070-15",
"ProductNDC": "21695-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keppra",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021035",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.",
"Description": "KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red. KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor."
},
{
"NDCCode": "21695-076-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (21695-076-15)",
"NDC11Code": "21695-0076-15",
"ProductNDC": "21695-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam tablet USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
},
{
"NDCCode": "21695-077-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (21695-077-15)",
"NDC11Code": "21695-0077-15",
"ProductNDC": "21695-077",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077927",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam tablet USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate."
}
]
}
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<NDCList>
<NDC>
<NDCCode>21695-146-15</NDCCode>
<PackageDescription>15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-146-15)</PackageDescription>
<NDC11Code>21695-0146-15</NDC11Code>
<ProductNDC>21695-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021427</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1)Efficacy was established in 4 short-term and one maintenance trial in adults (14.1)., 2 Generalized Anxiety Disorder (GAD) (1.2)Efficacy was established in 3 short-term and one maintenance trial in adults (14.2)., 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1.3), 4 Fibromyalgia (FM) (1.4).</IndicationAndUsage>
<Description>Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) 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 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, 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.</Description>
</NDC>
<NDC>
<NDCCode>21695-146-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (21695-146-30)</PackageDescription>
<NDC11Code>21695-0146-30</NDC11Code>
<ProductNDC>21695-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021427</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cymbalta® is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1)Efficacy was established in 4 short-term and one maintenance trial in adults (14.1)., 2 Generalized Anxiety Disorder (GAD) (1.2)Efficacy was established in 3 short-term and one maintenance trial in adults (14.2)., 3 Diabetic Peripheral Neuropathic Pain (DPNP) (1.3), 4 Fibromyalgia (FM) (1.4).</IndicationAndUsage>
<Description>Cymbalta® (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) 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 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, 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.</Description>
</NDC>
<NDC>
<NDCCode>10135-146-14</NDCCode>
<PackageDescription>15 g in 1 BOTTLE, PLASTIC (10135-146-14) </PackageDescription>
<NDC11Code>10135-0146-14</NDC11Code>
<ProductNDC>10135-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
<NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204071</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
<StrengthNumber>4.1</StrengthNumber>
<StrengthUnit>meq/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia.</IndicationAndUsage>
<Description>Sodium polystyrene sulfonate is a benzene, diethenyl- polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula. The drug is a golden brown finely ground, powdered form of sodium polystyrene sulfonate, a cation exchange resin prepared in the sodium phase with an in vitroexchange capacity of approximately 3.1 mEq ( in vivoapproximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema.</Description>
</NDC>
<NDC>
<NDCCode>16590-146-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (16590-146-15)</PackageDescription>
<NDC11Code>16590-0146-15</NDC11Code>
<ProductNDC>16590-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meclizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Meclizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19810603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087128</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC],Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.</IndicationAndUsage>
<Description>Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:. C25H27CIN22HCIH2O M.W. 481.89. The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate. Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration. *Contains FD&C Yellow #5 (see PRECAUTIONS). Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5.</Description>
</NDC>
<NDC>
<NDCCode>20276-146-15</NDCCode>
<PackageDescription>444 mL in 1 BOTTLE, PLASTIC (20276-146-15) </PackageDescription>
<NDC11Code>20276-0146-15</NDC11Code>
<ProductNDC>20276-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lucky</ProprietaryName>
<ProprietaryNameSuffix>Antibacterial</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Delta Brands, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-146-15</NDCCode>
<PackageDescription>14 g in 1 TUBE (24909-146-15) </PackageDescription>
<NDC11Code>24909-0146-15</NDC11Code>
<ProductNDC>24909-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Ipl Relief</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140314</StartMarketingDate>
<EndMarketingDate>20250315</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181229</StartMarketingDatePackage>
<EndMarketingDatePackage>20250315</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relief from symptoms of itch, papules (bumps) and lesions often associated with Molluscum per diagnosis and care by physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46144-146-01</NDCCode>
<PackageDescription>15 PATCH in 1 BOX (46144-146-01) > 100 g in 1 PATCH</PackageDescription>
<NDC11Code>46144-0146-01</NDC11Code>
<ProductNDC>46144-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solaice</ProprietaryName>
<NonProprietaryName>Menthol,capsaicin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>API Solutions, Inc.</LabelerName>
<SubstanceName>CAPSAICIN; MENTHOL</SubstanceName>
<StrengthNumber>.05; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-28</LastUpdate>
</NDC>
<NDC>
<NDCCode>53329-146-15</NDCCode>
<PackageDescription>198 g in 1 TUBE (53329-146-15) </PackageDescription>
<NDC11Code>53329-0146-15</NDC11Code>
<ProductNDC>53329-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medline</ProprietaryName>
<NonProprietaryName>White Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230301</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>WHITE PETROLATUM</SubstanceName>
<StrengthNumber>983</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230601</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-146-03</NDCCode>
<PackageDescription>15 kg in 1 CANISTER (64220-146-03) </PackageDescription>
<NDC11Code>64220-0146-03</NDC11Code>
<ProductNDC>64220-146</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240604</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-05</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-JUN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>64220-146-06</NDCCode>
<PackageDescription>15 kg in 1 DRUM (64220-146-06) </PackageDescription>
<NDC11Code>64220-0146-06</NDC11Code>
<ProductNDC>64220-146</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketotifen Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240604</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>KETOTIFEN FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-06-05</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>04-JUN-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66259-936-15</NDCCode>
<PackageDescription>1 KIT in 1 KIT (66259-936-15) * 10 mL in 1 VIAL, PLASTIC * 1 VIAL in 1 VIAL (66259-146-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (66259-146-01) </PackageDescription>
<NDC11Code>66259-0936-15</NDC11Code>
<ProductNDC>66259-936</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spy-mis Kit</ProprietaryName>
<NonProprietaryName>Indocyanine Green</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRADERMAL; INTRAVASCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190910</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211580</ApplicationNumber>
<LabelerName>Novadaq Technologies Inc</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SPY AGENT GREEN is an optical imaging agent indicated for use with a fluorescence imaging device for: : 1 Visualization of vessels (micro and macro vasculature), blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries including general minimally invasive surgical procedures in adults and pediatric patients one month of age and older. (1.1) , 2 Visualization of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older. (1.2) , 3 Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer. (1.3) , 4 Visualization of lymph nodes and lymphatic vessels during lymphatic mapping in adults with breast cancer. (1.4).</IndicationAndUsage>
<Description>SPY AGENT GREEN (indocyanine green for injection, USP) is a water soluble, optical imaging agent which is reconstituted with Sterile Water for Injection, USP, for intravenous, interstitial or intradermal use. Each vial contains a sterile, lyophilized, green powder containing 25 mg of indocyanine green with not more than 5% sodium iodide. Hydrochloric acid or sodium hydroxide may be used to adjust the pH prior to lyophilization. The chemical name for Indocyanine Green is 1 HBenz[e]indolium, 2-[7-[1,3-dihydro-1,1-dimethyl-3-(4-sulfobutyl)-2H-benz[e] indol-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-, hydroxide, inner salt, sodium salt. Molecular Formula: C 43H 47N 2NaO 6S 2; Molecular Mass: 774.96 g/mol, with the following structural formula:. Indocyanine green has a peak spectral absorption at 805 nm. SPY AGENT GREEN has a pH of 5.5 to 7.5 when reconstituted with Sterile Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>67046-146-15</NDCCode>
<PackageDescription>15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-146-15)</PackageDescription>
<NDC11Code>67046-0146-15</NDC11Code>
<ProductNDC>67046-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090070</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<Description>Divalproex sodium USP is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium USP has the following structure:. Divalproex sodium USP occurs as a white to off white powder with a characteristic odor, very soluble in chloroform, freely soluble in methanol and ethyl ether, soluble in acetone, practically insoluble in acetonitrile. Divalproex sodium extended-release tablets USP, 500 mg are for oral administration. Divalproex sodium extended-release tablets USP, contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to 500 mg of valproic acid. Inactive Ingredients. Divalproex sodium extended-release tablets USP, 500 mg: Hydroxy ethyl cellulose, hydroxy propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, silicon dioxide, and titanium dioxide. Divalproex sodium extended-release tablets meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>70700-146-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70700-146-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>70700-0146-15</NDC11Code>
<ProductNDC>70700-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212976</ApplicationNumber>
<LabelerName>Xiromed LLC</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Ointment, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide Ointment contains fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, white petrolatum, propylene carbonate, propylene glycol and white wax. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>71919-146-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-146-07) </PackageDescription>
<NDC11Code>71919-0146-07</NDC11Code>
<ProductNDC>71919-146</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Fluorica</ProprietaryName>
<NonProprietaryName>Calcium Fluoride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CALCIUM FLUORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>21695-002-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (21695-002-15)</PackageDescription>
<NDC11Code>21695-0002-15</NDC11Code>
<ProductNDC>21695-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ABILIFY is an atypical antipsychotic indicated as oral formulations for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1), 2 Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1).</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>21695-003-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (21695-003-15)</PackageDescription>
<NDC11Code>21695-0003-15</NDC11Code>
<ProductNDC>21695-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ABILIFY is an atypical antipsychotic indicated as oral formulations for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1), 2 Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1).</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>21695-004-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (21695-004-15)</PackageDescription>
<NDC11Code>21695-0004-15</NDC11Code>
<ProductNDC>21695-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abilify</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021436</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ABILIFY is an atypical antipsychotic indicated as oral formulations for the. Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1), 2 Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1).</IndicationAndUsage>
<Description>Aripiprazole is a psychotropic drug that is available as ABILIFY® (aripiprazole) Tablets, ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets, ABILIFY® (aripiprazole) Oral Solution, and ABILIFY® (aripiprazole) Injection, a solution for intramuscular injection. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. The empirical formula is C23H27Cl2N3O2 and its molecular weight is 448.38. The chemical structure is. ABILIFY Tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg strengths. Inactive ingredients include cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY DISCMELT Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. Inactive ingredients include acesulfame potassium, aspartame, calcium silicate, croscarmellose sodium, crospovidone, crème de vanilla (natural and artificial flavors), magnesium stearate, microcrystalline cellulose, silicon dioxide, tartaric acid, and xylitol. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake. ABILIFY Oral Solution is a clear, colorless to light yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors. ABILIFY Injection is available in single-dose vials as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) clear, colorless, sterile, aqueous solution for intramuscular use only. Inactive ingredients for this solution include 150 mg/mL of sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>21695-008-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (21695-008-15)</PackageDescription>
<NDC11Code>21695-0008-15</NDC11Code>
<ProductNDC>21695-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Use for temporary relief of minor aches and pains due to. ° headache ° muscular aches ° backache ° arthritis ° the common cold ° toothache ° menstrual cramps ° temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-022-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (21695-022-15)</PackageDescription>
<NDC11Code>21695-0022-15</NDC11Code>
<ProductNDC>21695-022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>21695-023-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (21695-023-15)</PackageDescription>
<NDC11Code>21695-0023-15</NDC11Code>
<ProductNDC>21695-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celebrex</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020998</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. CELEBREX oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>21695-035-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21695-035-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>21695-0035-15</NDC11Code>
<ProductNDC>21695-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19950601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). for effective relief of. itching. scaling. cracking. burning. redness. soreness. irritation. discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-037-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (21695-037-15)</PackageDescription>
<NDC11Code>21695-0037-15</NDC11Code>
<ProductNDC>21695-037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078218</ApplicationNumber>
<LabelerName>Rebel Distributors</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N·HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets 10 mg contain the following inactive ingredients: croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-045-15</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-045-15)</PackageDescription>
<NDC11Code>21695-0045-15</NDC11Code>
<ProductNDC>21695-045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-046-15</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-046-15)</PackageDescription>
<NDC11Code>21695-0046-15</NDC11Code>
<ProductNDC>21695-046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-047-15</NDCCode>
<PackageDescription>15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-047-15)</PackageDescription>
<NDC11Code>21695-0047-15</NDC11Code>
<ProductNDC>21695-047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder. The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-060-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (21695-060-15)</PackageDescription>
<NDC11Code>21695-0060-15</NDC11Code>
<ProductNDC>21695-060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Geodon</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020825</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON Capsules contain ziprasidone hydrochloride monohydrate, lactose, pregelatinized starch, and magnesium stearate. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS CH3SO3H 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [See Dosage and Administration (2.3)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
</NDC>
<NDC>
<NDCCode>21695-061-15</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (21695-061-15)</PackageDescription>
<NDC11Code>21695-0061-15</NDC11Code>
<ProductNDC>21695-061</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Geodon</ProprietaryName>
<NonProprietaryName>Ziprasidone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020825</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula. GEODON Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder. GEODON Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON Capsules contain ziprasidone hydrochloride monohydrate, lactose, pregelatinized starch, and magnesium stearate. GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS CH3SO3H 3H2O and its molecular weight is 563.09. GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [See Dosage and Administration (2.3)]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
</NDC>
<NDC>
<NDCCode>21695-070-15</NDCCode>
<PackageDescription>15 TABLET in 1 DRUM (21695-070-15)</PackageDescription>
<NDC11Code>21695-0070-15</NDC11Code>
<ProductNDC>21695-070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keppra</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021035</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.</IndicationAndUsage>
<Description>KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.). KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red. KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.</Description>
</NDC>
<NDC>
<NDCCode>21695-076-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (21695-076-15)</PackageDescription>
<NDC11Code>21695-0076-15</NDC11Code>
<ProductNDC>21695-076</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam tablet USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
<NDC>
<NDCCode>21695-077-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (21695-077-15)</PackageDescription>
<NDC11Code>21695-0077-15</NDC11Code>
<ProductNDC>21695-077</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077927</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam tablet USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.</Description>
</NDC>
</NDCList>