{
"NDC": [
{
"NDCCode": "0078-0827-60",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-0827-60) / .05 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-0827-60",
"ProductNDC": "0078-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beovu",
"NonProprietaryName": "Brolucizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20191007",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761125",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "BROLUCIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/.05mL",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220309",
"SamplePackage": "N",
"IndicationAndUsage": "BEOVU® is indicated for the treatment of.",
"Description": "Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in Escherichia coli cells by recombinant DNA technology. BEOVU (brolucizumab-dbll) injection is a sterile, clear to slightly opalescent, colorless to slightly brownish-yellow solution in a single-dose pre-filled syringe or a single-dose vial for intravitreal administration. Each single-dose pre-filled syringe and vial is designed to deliver 0.05 mL of solution containing 6 mg brolucizumab-dbll, polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), and Water for Injection, USP and with a pH of approximately 7.2. This product does not contain an antimicrobial preservative."
},
{
"NDCCode": "0078-0827-61",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-61) > .05 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00078-0827-61",
"ProductNDC": "0078-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beovu",
"NonProprietaryName": "Brolucizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20191007",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761125",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "BROLUCIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/.05mL",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191007",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0827-98",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0078-0827-98) / .05 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00078-0827-98",
"ProductNDC": "0078-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beovu",
"NonProprietaryName": "Brolucizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20191007",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761125",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "BROLUCIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/.05mL",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220309",
"SamplePackage": "Y",
"IndicationAndUsage": "BEOVU® is indicated for the treatment of.",
"Description": "Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in Escherichia coli cells by recombinant DNA technology. BEOVU (brolucizumab-dbll) injection is a sterile, clear to slightly opalescent, colorless to slightly brownish-yellow solution in a single-dose pre-filled syringe or a single-dose vial for intravitreal administration. Each single-dose pre-filled syringe and vial is designed to deliver 0.05 mL of solution containing 6 mg brolucizumab-dbll, polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), and Water for Injection, USP and with a pH of approximately 7.2. This product does not contain an antimicrobial preservative."
},
{
"NDCCode": "0078-0827-99",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-99) > .05 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00078-0827-99",
"ProductNDC": "0078-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Beovu",
"NonProprietaryName": "Brolucizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20191007",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761125",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "BROLUCIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/.05mL",
"Status": "Deprecated",
"LastUpdate": "2023-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191007",
"EndMarketingDatePackage": "20230228",
"SamplePackage": "Y"
},
{
"NDCCode": "0363-0827-60",
"PackageDescription": "1 BOTTLE in 1 BOX (0363-0827-60) / 60 TABLET in 1 BOTTLE",
"NDC11Code": "00363-0827-60",
"ProductNDC": "0363-0827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Laxative",
"ProprietaryNameSuffix": "Plus Stimulant",
"NonProprietaryName": "Docusate Sodium And Sennosides",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180930",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Walgreens",
"SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
"StrengthNumber": "50; 8.6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180930",
"SamplePackage": "N",
"IndicationAndUsage": "for overnight relief from occasional constipation (irregularity) . generally produces bowel movement in 6 to12 hours."
},
{
"NDCCode": "12634-827-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (12634-827-60)",
"NDC11Code": "12634-0827-60",
"ProductNDC": "12634-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070820",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075229",
"LabelerName": "APOTHECA, INC",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium tablets USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The structural formula is. C14H10Cl2KNO2 M.W. 334.25. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol and water, and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a single dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each tablet, for oral administration, contains 50 mg of diclofenac potassium. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, povidone, sodium starch glycolate, titanium dioxide, and tricalcium phosphate."
},
{
"NDCCode": "16590-827-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (16590-827-60)",
"NDC11Code": "16590-0827-60",
"ProductNDC": "16590-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydromorphone Hydrochloride",
"NonProprietaryName": "Hydromorphone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078273",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "HYDROMORPHONE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydromorphone hydrochloride tablets USP are indicated for the management of pain in patients where an opioid analgesic is appropriate.",
"Description": "Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg are supplied in tablet form for oral administration. Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of hydromorphone hydrochloride tablets USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula of hydromorphone hydrochloride is. Each Hydromorphone Hydrochloride Tablet USP, 2 mg contains:. Each Hydromorphone Hydrochloride Tablet USP, 4 mg contains:. Each Hydromorphone Hydrochloride Tablet USP, 8 mg contains:. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and stearic acid."
},
{
"NDCCode": "43353-827-60",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-60) ",
"NDC11Code": "43353-0827-60",
"ProductNDC": "43353-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111130",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020702",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130311",
"SamplePackage": "N",
"IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.",
"Description": "Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion."
},
{
"NDCCode": "50090-0827-3",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0827-3)",
"NDC11Code": "50090-0827-03",
"ProductNDC": "50090-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20031111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076048",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "53329-827-60",
"PackageDescription": "200 PACKET in 1 BOX (53329-827-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR",
"NDC11Code": "53329-0827-60",
"ProductNDC": "53329-827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Curad Alcohol Prep Pads",
"ProprietaryNameSuffix": "Medium",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121219",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Medline Industries, LP",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121219",
"SamplePackage": "N",
"IndicationAndUsage": "for preparation of the skin prior to injection. first aid antiseptic to help prevent infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "58411-827-60",
"PackageDescription": "1 TUBE in 1 CARTON (58411-827-60) > 50 mL in 1 TUBE",
"NDC11Code": "58411-0827-60",
"ProductNDC": "58411-827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum Spf 25 Sunscreen 1w1 Porcelain",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laura Mercier Cosmetics",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "1.53; 2.55; 2.55; 1.53",
"StrengthUnit": "g/50mL; g/50mL; g/50mL; g/50mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "62037-827-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-827-60)",
"NDC11Code": "62037-0827-60",
"ProductNDC": "62037-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075416",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63187-827-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-60) ",
"NDC11Code": "63187-0827-60",
"ProductNDC": "63187-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203458",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140601",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide."
},
{
"NDCCode": "71205-827-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (71205-827-60) ",
"NDC11Code": "71205-0827-60",
"ProductNDC": "71205-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077856",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230814",
"SamplePackage": "N",
"Description": "Clonazepam Tablets USP, a benzodiazepine, is available as scored tablets containing 0.5 mg of clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "71335-0827-2",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71335-0827-2) ",
"NDC11Code": "71335-0827-02",
"ProductNDC": "71335-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204597",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2019-03-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160629",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine is indicated for the treatment of. Fluoxetine and Olanzapine in Combination is indicated for the treatment of. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "71610-827-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-827-60) ",
"NDC11Code": "71610-0827-60",
"ProductNDC": "71610-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240502",
"SamplePackage": "N",
"IndicationAndUsage": "Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.",
"Description": "Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium."
},
{
"NDCCode": "0006-0078-61",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) ",
"NDC11Code": "00006-0078-61",
"ProductNDC": "0006-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Janumet",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Sitagliptin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202270",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "50; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120202",
"SamplePackage": "N",
"IndicationAndUsage": "JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release."
},
{
"NDCCode": "0078-0323-44",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0078-0323-44) ",
"NDC11Code": "00078-0323-44",
"ProductNDC": "0078-0323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020823",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20000430",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0324-44",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0078-0324-44) ",
"NDC11Code": "00078-0324-44",
"ProductNDC": "0078-0324",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020823",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20000430",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0325-44",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0078-0325-44) ",
"NDC11Code": "00078-0325-44",
"ProductNDC": "0078-0325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020823",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20000430",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0326-44",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (0078-0326-44) ",
"NDC11Code": "00078-0326-44",
"ProductNDC": "0078-0326",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exelon",
"NonProprietaryName": "Rivastigmine Tartrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020823",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "RIVASTIGMINE TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20000430",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0414-20",
"PackageDescription": "60 BLISTER PACK in 1 BOX (0078-0414-20) / 1 TABLET in 1 BLISTER PACK (0078-0414-61) ",
"NDC11Code": "00078-0414-20",
"ProductNDC": "0078-0414",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zortress",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021560",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100422",
"SamplePackage": "N",
"IndicationAndUsage": "Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).",
"Description": "Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "0078-0415-20",
"PackageDescription": "60 BLISTER PACK in 1 BOX (0078-0415-20) / 1 TABLET in 1 BLISTER PACK (0078-0415-61) ",
"NDC11Code": "00078-0415-20",
"ProductNDC": "0078-0415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zortress",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021560",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100422",
"SamplePackage": "N",
"IndicationAndUsage": "Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).",
"Description": "Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "0078-0417-20",
"PackageDescription": "60 BLISTER PACK in 1 BOX (0078-0417-20) / 1 TABLET in 1 BLISTER PACK (0078-0417-61) ",
"NDC11Code": "00078-0417-20",
"ProductNDC": "0078-0417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zortress",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021560",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100422",
"SamplePackage": "N",
"IndicationAndUsage": "Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).",
"Description": "Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "0078-0422-20",
"PackageDescription": "60 BLISTER PACK in 1 BOX (0078-0422-20) / 1 TABLET in 1 BLISTER PACK (0078-0422-61) ",
"NDC11Code": "00078-0422-20",
"ProductNDC": "0078-0422",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zortress",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021560",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180810",
"SamplePackage": "N",
"IndicationAndUsage": "Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).",
"Description": "Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients."
},
{
"NDCCode": "0078-0509-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (0078-0509-20) ",
"NDC11Code": "00078-0509-20",
"ProductNDC": "0078-0509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tegretol",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19680311",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016608",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170406",
"SamplePackage": "N",
"IndicationAndUsage": "Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol (see PRECAUTIONS, General).",
"Description": "Tegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg, XR tablets of 100, 200, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f ]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients. Tablets: Colloidal silicon dioxide, FD&C Red No. 40, gelatin, glycerin, magnesium stearate, starch, and stearic acid. Suspension: Citric acid, FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene glycol, purified water, sorbitol, sucrose, and xanthan gum. The amount of propylene glycol in Tegretol suspension is 25 mg per mL (see WARNINGS Propylene Glycol Toxicity). Tegretol-XR tablets: cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg tablets only)."
},
{
"NDCCode": "0078-0595-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (0078-0595-20)",
"NDC11Code": "00078-0595-20",
"ProductNDC": "0078-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fanapt",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022192",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0078-0596-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (0078-0596-20)",
"NDC11Code": "00078-0596-20",
"ProductNDC": "0078-0596",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fanapt",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022192",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0078-0597-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (0078-0597-20)",
"NDC11Code": "00078-0597-20",
"ProductNDC": "0078-0597",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fanapt",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022192",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0078-0598-20",
"PackageDescription": "60 TABLET in 1 BOTTLE (0078-0598-20)",
"NDC11Code": "00078-0598-20",
"ProductNDC": "0078-0598",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fanapt",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022192",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0078-0827-60</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0078-0827-60) / .05 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00078-0827-60</NDC11Code>
<ProductNDC>0078-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beovu</ProprietaryName>
<NonProprietaryName>Brolucizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20191007</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761125</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>BROLUCIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BEOVU® is indicated for the treatment of.</IndicationAndUsage>
<Description>Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in Escherichia coli cells by recombinant DNA technology. BEOVU (brolucizumab-dbll) injection is a sterile, clear to slightly opalescent, colorless to slightly brownish-yellow solution in a single-dose pre-filled syringe or a single-dose vial for intravitreal administration. Each single-dose pre-filled syringe and vial is designed to deliver 0.05 mL of solution containing 6 mg brolucizumab-dbll, polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), and Water for Injection, USP and with a pH of approximately 7.2. This product does not contain an antimicrobial preservative.</Description>
</NDC>
<NDC>
<NDCCode>0078-0827-61</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-61) > .05 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00078-0827-61</NDC11Code>
<ProductNDC>0078-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beovu</ProprietaryName>
<NonProprietaryName>Brolucizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20191007</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761125</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>BROLUCIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191007</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0827-98</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0078-0827-98) / .05 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00078-0827-98</NDC11Code>
<ProductNDC>0078-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beovu</ProprietaryName>
<NonProprietaryName>Brolucizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20191007</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761125</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>BROLUCIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220309</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BEOVU® is indicated for the treatment of.</IndicationAndUsage>
<Description>Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in Escherichia coli cells by recombinant DNA technology. BEOVU (brolucizumab-dbll) injection is a sterile, clear to slightly opalescent, colorless to slightly brownish-yellow solution in a single-dose pre-filled syringe or a single-dose vial for intravitreal administration. Each single-dose pre-filled syringe and vial is designed to deliver 0.05 mL of solution containing 6 mg brolucizumab-dbll, polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), and Water for Injection, USP and with a pH of approximately 7.2. This product does not contain an antimicrobial preservative.</Description>
</NDC>
<NDC>
<NDCCode>0078-0827-99</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0827-99) > .05 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00078-0827-99</NDC11Code>
<ProductNDC>0078-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Beovu</ProprietaryName>
<NonProprietaryName>Brolucizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20191007</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761125</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>BROLUCIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.05mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191007</StartMarketingDatePackage>
<EndMarketingDatePackage>20230228</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0827-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (0363-0827-60) / 60 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00363-0827-60</NDC11Code>
<ProductNDC>0363-0827</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Laxative</ProprietaryName>
<ProprietaryNameSuffix>Plus Stimulant</ProprietaryNameSuffix>
<NonProprietaryName>Docusate Sodium And Sennosides</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180930</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
<StrengthNumber>50; 8.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for overnight relief from occasional constipation (irregularity) . generally produces bowel movement in 6 to12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12634-827-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (12634-827-60)</PackageDescription>
<NDC11Code>12634-0827-60</NDC11Code>
<ProductNDC>12634-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Potassium</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070820</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075229</ApplicationNumber>
<LabelerName>APOTHECA, INC</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac potassium tablets are indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium tablets USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The structural formula is. C14H10Cl2KNO2 M.W. 334.25. Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol and water, and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a single dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each tablet, for oral administration, contains 50 mg of diclofenac potassium. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, povidone, sodium starch glycolate, titanium dioxide, and tricalcium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>16590-827-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16590-827-60)</PackageDescription>
<NDC11Code>16590-0827-60</NDC11Code>
<ProductNDC>16590-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydromorphone Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydromorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078273</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>HYDROMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydromorphone hydrochloride tablets USP are indicated for the management of pain in patients where an opioid analgesic is appropriate.</IndicationAndUsage>
<Description>Hydromorphone Hydrochloride Tablets USP, 2 mg, 4 mg, and 8 mg are supplied in tablet form for oral administration. Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. The chemical name of hydromorphone hydrochloride tablets USP is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula of hydromorphone hydrochloride is. Each Hydromorphone Hydrochloride Tablet USP, 2 mg contains:. Each Hydromorphone Hydrochloride Tablet USP, 4 mg contains:. Each Hydromorphone Hydrochloride Tablet USP, 8 mg contains:. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>43353-827-60</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-60) </PackageDescription>
<NDC11Code>43353-0827-60</NDC11Code>
<ProductNDC>43353-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111130</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020702</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.</IndicationAndUsage>
<Description>Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Atorvastatin calcium is [R-(R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium is (C33H34 FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is. Atorvastatin calcium is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, USP; candelilla wax, FCC; croscarmellose sodium, NF; hydroxypropyl cellulose, NF; lactose monohydrate, NF; magnesium stearate, NF; microcrystalline cellulose, NF; Opadry White YS-1-7040 (hypromellose, polyethylene glycol, talc, titanium dioxide); polysorbate 80, NF; simethicone emulsion.</Description>
</NDC>
<NDC>
<NDCCode>50090-0827-3</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-0827-3)</PackageDescription>
<NDC11Code>50090-0827-03</NDC11Code>
<ProductNDC>50090-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076048</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>53329-827-60</NDCCode>
<PackageDescription>200 PACKET in 1 BOX (53329-827-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>53329-0827-60</NDC11Code>
<ProductNDC>53329-827</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Curad Alcohol Prep Pads</ProprietaryName>
<ProprietaryNameSuffix>Medium</ProprietaryNameSuffix>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Medline Industries, LP</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for preparation of the skin prior to injection. first aid antiseptic to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58411-827-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (58411-827-60) > 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0827-60</NDC11Code>
<ProductNDC>58411-827</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum Spf 25 Sunscreen 1w1 Porcelain</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laura Mercier Cosmetics</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>1.53; 2.55; 2.55; 1.53</StrengthNumber>
<StrengthUnit>g/50mL; g/50mL; g/50mL; g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62037-827-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-827-60)</PackageDescription>
<NDC11Code>62037-0827-60</NDC11Code>
<ProductNDC>62037-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075416</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>750</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>2018-10-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63187-827-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-827-60) </PackageDescription>
<NDC11Code>63187-0827-60</NDC11Code>
<ProductNDC>63187-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203458</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-827-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (71205-827-60) </PackageDescription>
<NDC11Code>71205-0827-60</NDC11Code>
<ProductNDC>71205-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077856</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230814</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Clonazepam Tablets USP, a benzodiazepine, is available as scored tablets containing 0.5 mg of clonazepam and unscored tablets containing 1 mg or 2 mg of clonazepam. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>71335-0827-2</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71335-0827-2) </PackageDescription>
<NDC11Code>71335-0827-02</NDC11Code>
<ProductNDC>71335-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204597</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine is indicated for the treatment of. Fluoxetine and Olanzapine in Combination is indicated for the treatment of. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.When using Fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C17H18F3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water.Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition, 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>71610-827-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-827-60) </PackageDescription>
<NDC11Code>71610-0827-60</NDC11Code>
<ProductNDC>71610-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lorazepam</ProprietaryName>
<NonProprietaryName>Lorazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076045</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>LORAZEPAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Lorazepam USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:. It is a white or practically white, crystalline powder, practically insoluble in water, sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and Ether, sparingly or slightly soluble in Dichloromethane. Soluble in Acetone and glacial Acetic acid. Each lorazepam tablet, USP, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, USP. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.</Description>
</NDC>
<NDC>
<NDCCode>0006-0078-61</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0006-0078-61) </PackageDescription>
<NDC11Code>00006-0078-61</NDC11Code>
<ProductNDC>0006-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Janumet</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Sitagliptin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202270</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin extended-release.</Description>
</NDC>
<NDC>
<NDCCode>0078-0323-44</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0078-0323-44) </PackageDescription>
<NDC11Code>00078-0323-44</NDC11Code>
<ProductNDC>0078-0323</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020823</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0324-44</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0078-0324-44) </PackageDescription>
<NDC11Code>00078-0324-44</NDC11Code>
<ProductNDC>0078-0324</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020823</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0325-44</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0078-0325-44) </PackageDescription>
<NDC11Code>00078-0325-44</NDC11Code>
<ProductNDC>0078-0325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020823</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0326-44</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (0078-0326-44) </PackageDescription>
<NDC11Code>00078-0326-44</NDC11Code>
<ProductNDC>0078-0326</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exelon</ProprietaryName>
<NonProprietaryName>Rivastigmine Tartrate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000430</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020823</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>RIVASTIGMINE TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0414-20</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 BOX (0078-0414-20) / 1 TABLET in 1 BLISTER PACK (0078-0414-61) </PackageDescription>
<NDC11Code>00078-0414-20</NDC11Code>
<ProductNDC>0078-0414</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zortress</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021560</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0078-0415-20</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 BOX (0078-0415-20) / 1 TABLET in 1 BLISTER PACK (0078-0415-61) </PackageDescription>
<NDC11Code>00078-0415-20</NDC11Code>
<ProductNDC>0078-0415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zortress</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021560</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0078-0417-20</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 BOX (0078-0417-20) / 1 TABLET in 1 BLISTER PACK (0078-0417-61) </PackageDescription>
<NDC11Code>00078-0417-20</NDC11Code>
<ProductNDC>0078-0417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zortress</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021560</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0078-0422-20</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 BOX (0078-0422-20) / 1 TABLET in 1 BLISTER PACK (0078-0422-61) </PackageDescription>
<NDC11Code>00078-0422-20</NDC11Code>
<ProductNDC>0078-0422</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zortress</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021560</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zortress is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving a. Kidney Transplant: At low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids (1.1). Liver Transplant: Administer no earlier than 30 days posttransplant. Use in combination with tacrolimus (reduced doses) and corticosteroids (1.2, 5.5). Limitations of Use: Safety and efficacy have not been established in the following: 1 Kidney transplant patients at high immunologic risk (1.3), 2 Recipients of transplanted organs other than kidney or liver (1.3, 5.7), 3 Pediatric patients (less than 18 years) (1.3).</IndicationAndUsage>
<Description>Zortress (everolimus) is a macrolide immunosuppressant. The chemical name of everolimus is (1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.25 g/mol. The structural formula is. Zortress is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg of everolimus together with butylated hydroxytoluene, crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, and magnesium stearate as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>0078-0509-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0078-0509-20) </PackageDescription>
<NDC11Code>00078-0509-20</NDC11Code>
<ProductNDC>0078-0509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tegretol</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19680311</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016608</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol (see PRECAUTIONS, General).</IndicationAndUsage>
<Description>Tegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg, XR tablets of 100, 200, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f ]azepine-5-carboxamide, and its structural formula is. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Inactive Ingredients. Tablets: Colloidal silicon dioxide, FD&C Red No. 40, gelatin, glycerin, magnesium stearate, starch, and stearic acid. Suspension: Citric acid, FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene glycol, purified water, sorbitol, sucrose, and xanthan gum. The amount of propylene glycol in Tegretol suspension is 25 mg per mL (see WARNINGS Propylene Glycol Toxicity). Tegretol-XR tablets: cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg tablets only).</Description>
</NDC>
<NDC>
<NDCCode>0078-0595-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0078-0595-20)</PackageDescription>
<NDC11Code>00078-0595-20</NDC11Code>
<ProductNDC>0078-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fanapt</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022192</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0078-0596-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0078-0596-20)</PackageDescription>
<NDC11Code>00078-0596-20</NDC11Code>
<ProductNDC>0078-0596</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fanapt</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022192</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0078-0597-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0078-0597-20)</PackageDescription>
<NDC11Code>00078-0597-20</NDC11Code>
<ProductNDC>0078-0597</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fanapt</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022192</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0078-0598-20</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0078-0598-20)</PackageDescription>
<NDC11Code>00078-0598-20</NDC11Code>
<ProductNDC>0078-0598</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fanapt</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022192</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>