{
"NDC": [
{
"NDCCode": "62856-270-14",
"PackageDescription": "1 KIT in 1 CARTON (62856-270-14)",
"NDC11Code": "62856-0270-14",
"ProductNDC": "62856-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fycompa",
"NonProprietaryName": "Perampanel",
"DosageFormName": "KIT",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202834",
"LabelerName": "Eisai Inc.",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "62856-272-14",
"PackageDescription": "14 TABLET in 1 PACKET (62856-272-14) ",
"NDC11Code": "62856-0272-14",
"ProductNDC": "62856-272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fycompa",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202834",
"LabelerName": "Eisai Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180808",
"SamplePackage": "Y",
"IndicationAndUsage": "FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "FYCOMPA tablets and oral suspension contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure is. Tablets. FYCOMPA tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C Blue No. 2 (indigo carmine) aluminum lake (10 mg and 12 mg). Oral Suspension. FYCOMPA oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate and purified water."
},
{
"NDCCode": "62856-274-14",
"PackageDescription": "14 TABLET in 1 PACKET (62856-274-14) ",
"NDC11Code": "62856-0274-14",
"ProductNDC": "62856-274",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fycompa",
"NonProprietaryName": "Perampanel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202834",
"LabelerName": "Eisai Inc.",
"SubstanceName": "PERAMPANEL",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180808",
"SamplePackage": "Y",
"IndicationAndUsage": "FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).",
"Description": "FYCOMPA tablets and oral suspension contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure is. Tablets. FYCOMPA tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C Blue No. 2 (indigo carmine) aluminum lake (10 mg and 12 mg). Oral Suspension. FYCOMPA oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate and purified water."
},
{
"NDCCode": "62856-583-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14) ",
"NDC11Code": "62856-0583-14",
"ProductNDC": "62856-583",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Banzel",
"NonProprietaryName": "Rufinamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021911",
"LabelerName": "Eisai Inc.",
"SubstanceName": "RUFINAMIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180808",
"SamplePackage": "Y",
"IndicationAndUsage": "BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.",
"Description": "BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2. The drug substance is a white, crystalline, odorless, and slightly bitter tasting neutral powder. Rufinamide is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. BANZEL is available for oral administration in film-coated tablets, scored on both sides, containing 200 and 400 mg of rufinamide. Inactive ingredients are colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate. The film coating contains hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. BANZEL is also available for oral administration as a liquid containing rufinamide at a concentration of 40 mg/mL. Inactive ingredients include microcrystalline cellulose and carboxymethylcellulose sodium, hydroxyethylcellulose, anhydrous citric acid, simethicone emulsion 30%, poloxamer 188, methylparaben, propylparaben, propylene glycol, potassium sorbate, noncrystallizing sorbitol solution 70%, and an orange flavor."
},
{
"NDCCode": "10544-270-14",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (10544-270-14)",
"NDC11Code": "10544-0270-14",
"ProductNDC": "10544-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070044",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets, USP 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, USP 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, USP in cases of reinfection. Amebiasis. Metronidazole tablets, USP 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 USP 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, USP. 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, USP and other antibacterial drugs, metronidazole tablets, USP 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, USP, 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 250 mg and 500 mg tablets, USP, for oral administration, contain the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "13733-270-01",
"PackageDescription": "14 g in 1 CARTON (13733-270-01)",
"NDC11Code": "13733-0270-01",
"ProductNDC": "13733-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha The Original Tension Pact Perfect Cover Spf37 No 13",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide,",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Able C&C Co., Ltd.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "5; 12.6; 2.94",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-10-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "21695-270-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (21695-270-14)",
"NDC11Code": "21695-0270-14",
"ProductNDC": "21695-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040748",
"LabelerName": "Rebel Distributors Corp.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "7.5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain."
},
{
"NDCCode": "46708-270-14",
"PackageDescription": "126 CAPSULE in 1 CARTON (46708-270-14) ",
"NDC11Code": "46708-0270-14",
"ProductNDC": "46708-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150822",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].",
"Description": "Celecoxib USP is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake."
},
{
"NDCCode": "54340-270-14",
"PackageDescription": "1356 g in 1 CELLO PACK (54340-270-14) ",
"NDC11Code": "54340-0270-14",
"ProductNDC": "54340-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Complete Antibacterial Bar",
"ProprietaryNameSuffix": "Spring Water",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210308",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230131",
"SamplePackage": "N",
"IndicationAndUsage": "Use. For washing to decrease bacteria on the skin."
},
{
"NDCCode": "54340-270-23",
"PackageDescription": "4 CELLO PACK in 1 CARTON (54340-270-23) / 1356 g in 1 CELLO PACK (54340-270-14) ",
"NDC11Code": "54340-0270-23",
"ProductNDC": "54340-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Complete Antibacterial Bar",
"ProprietaryNameSuffix": "Spring Water",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210308",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230201",
"SamplePackage": "N",
"IndicationAndUsage": "Use. For washing to decrease bacteria on the skin."
},
{
"NDCCode": "63776-270-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-270-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0270-14",
"ProductNDC": "63776-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ithurts",
"NonProprietaryName": "Anti-interleukin-1.alpha. Apomorphine, Metenkefalin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; METENKEFALIN",
"StrengthNumber": "200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120326",
"SamplePackage": "N",
"IndicationAndUsage": "To help with inflammatory & pain symptoms."
},
{
"NDCCode": "67046-270-14",
"PackageDescription": "14 TABLET, FILM COATED in 1 BLISTER PACK (67046-270-14) ",
"NDC11Code": "67046-0270-14",
"ProductNDC": "67046-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171002",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171002",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "69716-270-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (69716-270-02) > 14 g in 1 BOTTLE, PLASTIC (69716-270-01) ",
"NDC11Code": "69716-0270-02",
"ProductNDC": "69716-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nots Crystal Cc Cushion No 23",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Octisalate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NoTS Co.,Ltd",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "1.96; 1.05; .7",
"StrengthUnit": "g/14g; g/14g; g/14g",
"Status": "Deprecated",
"LastUpdate": "2019-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20161201",
"SamplePackage": "N"
},
{
"NDCCode": "69842-270-14",
"PackageDescription": "1 BOTTLE in 1 CARTON (69842-270-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "69842-0270-14",
"ProductNDC": "69842-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202194",
"LabelerName": "CVS Health Corp",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201223",
"SamplePackage": "N"
},
{
"NDCCode": "69842-270-28",
"PackageDescription": "2 BOTTLE in 1 CARTON (69842-270-28) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "69842-0270-28",
"ProductNDC": "69842-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202194",
"LabelerName": "CVS Health Corp",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201223",
"SamplePackage": "N"
},
{
"NDCCode": "69842-270-42",
"PackageDescription": "3 BOTTLE in 1 CARTON (69842-270-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "69842-0270-42",
"ProductNDC": "69842-270",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20201223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202194",
"LabelerName": "CVS Health Corp",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201223",
"SamplePackage": "N"
},
{
"NDCCode": "72789-270-14",
"PackageDescription": "14 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-14) ",
"NDC11Code": "72789-0270-14",
"ProductNDC": "72789-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Macrocrystals",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20070308",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073652",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220901",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin Capsules USP (Macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiellaand Enterobacterspecies. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (Macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules USP (Macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules USP (Macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules USP (Macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin Capsules, USP (Macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Capsules, USP (Macrocrystals) are an antibacterial agent for specific urinary tract infections. Nitrofurantoin, USP (macrocrystals) is chemically designated as 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]amino]- and has the following structural formula. C 8H 6N 4O 5(anhydrous) M.W. 238.16. Each capsule, for oral administration, contains 50 mg or 100 mg of nitrofurantoin, USP (macrocrystals). In addition, each capsule contains the following inactive ingredients: corn starch, edible black ink (black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, shellac glaze), gelatin, lactose monohydrate, talc, titanium dioxide and colorant D&C Red No. 33."
},
{
"NDCCode": "73069-270-14",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-270-14) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0270-14",
"ProductNDC": "73069-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-ithurts",
"NonProprietaryName": "Anti-interleukin-1.alpha. Apomorphine, Metenkefalin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; BETA-ENDORPHIN HUMAN",
"StrengthNumber": "201; 201; 201",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "85766-270-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (85766-270-14) ",
"NDC11Code": "85766-0270-14",
"ProductNDC": "85766-270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209553",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260905",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1) : 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir Tablets, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, hypromellose, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone K90, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13H 20N 6O 4∙HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "62856-405-10",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "62856-0405-10",
"ProductNDC": "62856-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dayvigo",
"NonProprietaryName": "Lemborexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212028",
"LabelerName": "Eisai Inc.",
"SubstanceName": "LEMBOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "Y",
"IndicationAndUsage": "DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].",
"Description": "DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet."
},
{
"NDCCode": "62856-405-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) ",
"NDC11Code": "62856-0405-30",
"ProductNDC": "62856-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dayvigo",
"NonProprietaryName": "Lemborexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212028",
"LabelerName": "Eisai Inc.",
"SubstanceName": "LEMBOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N",
"IndicationAndUsage": "DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].",
"Description": "DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet."
},
{
"NDCCode": "62856-405-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90) ",
"NDC11Code": "62856-0405-90",
"ProductNDC": "62856-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dayvigo",
"NonProprietaryName": "Lemborexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212028",
"LabelerName": "Eisai Inc.",
"SubstanceName": "LEMBOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N",
"IndicationAndUsage": "DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].",
"Description": "DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet."
},
{
"NDCCode": "62856-410-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (62856-410-30) ",
"NDC11Code": "62856-0410-30",
"ProductNDC": "62856-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dayvigo",
"NonProprietaryName": "Lemborexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212028",
"LabelerName": "Eisai Inc.",
"SubstanceName": "LEMBOREXANT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N",
"IndicationAndUsage": "DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].",
"Description": "DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet."
},
{
"NDCCode": "62856-410-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (62856-410-90) ",
"NDC11Code": "62856-0410-90",
"ProductNDC": "62856-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dayvigo",
"NonProprietaryName": "Lemborexant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212028",
"LabelerName": "Eisai Inc.",
"SubstanceName": "LEMBOREXANT",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200407",
"SamplePackage": "N",
"IndicationAndUsage": "DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].",
"Description": "DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet."
},
{
"NDCCode": "0074-4456-04",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (0074-4456-04) ",
"NDC11Code": "00074-4456-04",
"ProductNDC": "0074-4456",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultane",
"NonProprietaryName": "Sevoflurane",
"DosageFormName": "LIQUID",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19950607",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020478",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "SEVOFLURANE",
"StrengthNumber": "250",
"StrengthUnit": "mL/250mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19950607",
"SamplePackage": "N",
"IndicationAndUsage": "ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.",
"Description": "ULTANE (sevoflurane), volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is:. Sevoflurane is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane is a clear, colorless, liquid containing no additives. Sevoflurane is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane occurs in the presence of strong acids or heat. When in contact with alkaline CO2 absorbents (e.g., Baralyme® and to a lesser extent soda lime) within the anesthesia machine, sevoflurane can undergo degradation under certain conditions. Degradation of sevoflurane is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane degradation and subsequent degradant formation are enhanced by increasing absorbent temperature increased sevoflurane concentration, decreased fresh gas flow and desiccated CO2 absorbents (especially with potassium hydroxide containing absorbents e.g., Baralyme). Sevoflurane alkaline degradation occurs by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropenyl fluoromethyl ether, (PIFE, C4H2F6O), also known as Compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether, (PMFE, C5H6F6O), also known as Compound B. The second pathway for degradation of sevoflurane, which occurs primarily in the presence of desiccated CO2 absorbents, is discussed later. In the first pathway, the defluorination pathway, the production of degradants in the anesthesia circuit results from the extraction of the acidic proton in the presence of a strong base (KOH and/or NaOH) forming an alkene (Compound A) from sevoflurane similar to formation of 2-bromo-2-chloro-1,1-difluoro ethylene (BCDFE) from halothane. Laboratory simulations have shown that the concentration of these degradants is inversely correlated with the fresh gas flow rate (See Figure 1). Since the reaction of carbon dioxide with absorbents is exothermic, the temperature increase will be determined by quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anesthesia circle system, metabolic status of the patient, and ventilation. The relationship of temperature produced by varying levels of CO2 and Compound A production is illustrated in the following in vitro simulation where CO2 was added to a circle absorber system. Compound A concentration in a circle absorber system increases as a function of increasing CO2 absorbent temperature and composition (Baralyme producing higher levels than soda lime), increased body temperature, and increased minute ventilation, and decreasing fresh gas flow rates. It has been reported that the concentration of Compound A increases significantly with prolonged dehydration of Baralyme. Compound A exposure in patients also has been shown to rise with increased sevoflurane concentrations and duration of anesthesia. In a clinical study in which sevoflurane was administered to patients under low flow conditions for ≥ 2 hours at flow rates of 1 Liter/minute, Compound A levels were measured in an effort to determine the relationship between MAC hours and Compound A levels produced. The relationship between Compound A levels and sevoflurane exposure are shown in Figure 2a. Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female). An experiment was performed comparing sevoflurane plus 75 or 100 ppm Compound A with an active control to evaluate the potential nephrotoxicity of Compound A in non-human primates. A single 8-hour exposure of Sevoflurane in the presence of Compound A produced single-cell renal tubular degeneration and single-cell necrosis in cynomolgus monkeys. These changes are consistent with the increased urinary protein, glucose level and enzymic activity noted on days one and three on the clinical pathology evaluation. This nephrotoxicity produced by Compound A is dose and duration of exposure dependent. At a fresh gas flow rate of 1 L/min, mean maximum concentrations of Compound A in the anesthesia circuit in clinical settings are approximately 20 ppm (0.002%) with soda lime and 30 ppm (0.003%) with Baralyme in adult patients; mean maximum concentrations in pediatric patients with soda lime are about half those found in adults. The highest concentration observed in a single patient with Baralyme was 61 ppm (0.0061%) and 32 ppm (0.0032%) with soda lime. The levels of Compound A at which toxicity occurs in humans is not known. The second pathway for degradation of sevoflurane occurs primarily in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated and cleared by the liver. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature that can be associated with desiccated Baralyme®. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. Sevoflurane degradants were observed in the respiratory circuit of an experimental anesthesia machine using desiccated CO2 absorbents and maximum sevoflurane concentrations (8%) for extended periods of time (> 2 hours). Concentrations of formaldehyde observed with desiccated soda lime in this experimental anesthesia respiratory circuit were consistent with levels that could potentially result in respiratory irritation. Although KOH containing CO2 absorbents are no longer commercially available, in the laboratory experiments, exposure of sevoflurane to the desiccated KOH containing CO2 absorbent, Baralyme, resulted in the detection of substantially greater degradant levels."
},
{
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"ProductNDC": "0115-1565",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209677",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
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"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The film coating for the 14 mg tablet is made of titanium dioxide, talcum, hypromellose, cottonseed oil and FD&C Blue no. 2 Al-Lake and FD&C Red No. 40."
},
{
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"NDC11Code": "00378-0627-93",
"ProductNDC": "0378-0627",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209702",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-01",
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"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-α,α,α-trifluoro-3-hydroxy-4-crotonotoluidide. Its molecular weight is 270.21, and the molecular formula is C12 H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide. The 7 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake and the 14 mg tablets also contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "0378-0628-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0628-93) ",
"NDC11Code": "00378-0628-93",
"ProductNDC": "0378-0628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209702",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230331",
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"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-α,α,α-trifluoro-3-hydroxy-4-crotonotoluidide. Its molecular weight is 270.21, and the molecular formula is C12 H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide. The 7 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake and the 14 mg tablets also contain red iron oxide and yellow iron oxide."
},
{
"NDCCode": "0480-3156-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3156-56) ",
"NDC11Code": "00480-3156-56",
"ProductNDC": "0480-3156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209700",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "0480-3157-56",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0480-3157-56) ",
"NDC11Code": "00480-3157-56",
"ProductNDC": "0480-3157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriflunomide",
"NonProprietaryName": "Teriflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209700",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "TERIFLUNOMIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.",
"Description": "Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow."
}
]
}
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<NDCList>
<NDC>
<NDCCode>62856-270-14</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (62856-270-14)</PackageDescription>
<NDC11Code>62856-0270-14</NDC11Code>
<ProductNDC>62856-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fycompa</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202834</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>62856-272-14</NDCCode>
<PackageDescription>14 TABLET in 1 PACKET (62856-272-14) </PackageDescription>
<NDC11Code>62856-0272-14</NDC11Code>
<ProductNDC>62856-272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fycompa</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202834</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180808</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>FYCOMPA tablets and oral suspension contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure is. Tablets. FYCOMPA tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C Blue No. 2 (indigo carmine) aluminum lake (10 mg and 12 mg). Oral Suspension. FYCOMPA oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62856-274-14</NDCCode>
<PackageDescription>14 TABLET in 1 PACKET (62856-274-14) </PackageDescription>
<NDC11Code>62856-0274-14</NDC11Code>
<ProductNDC>62856-274</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fycompa</ProprietaryName>
<NonProprietaryName>Perampanel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202834</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>PERAMPANEL</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180808</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FYCOMPA, a non-competitive AMPA glutamate receptor antagonist, is indicated for: 1 Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older (1.1), 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older (1.2).</IndicationAndUsage>
<Description>FYCOMPA tablets and oral suspension contain perampanel, a non-competitive AMPA receptor antagonist, as a 4:3 hydrate. The chemical name of the active ingredient is 2-(1′,6′-dihydro-6′-oxo-1′-phenyl[2,3′-bipyridin]-5′-yl)-benzonitrile, hydrate (4:3). The molecular formula is C23H15N3O ¾H2O and the molecular weight is 362.90 (349.39 for anhydrous perampanel). It is a white to yellowish white powder. It is freely soluble in 1-methyl-2-pyrrolidinone, sparingly soluble in acetonitrile and acetone, slightly soluble in methanol, ethanol and ethyl acetate, very slightly soluble in 1-octanol and diethyl ether, and practically insoluble in heptane and water. The chemical structure is. Tablets. FYCOMPA tablets are round, bi-convex, film-coated tablets containing 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of perampanel. Tablets contain the following inactive ingredients: lactose monohydrate, low substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate, hypromellose, polyethylene glycol, talc, and titanium dioxide. Tablets of different strengths may contain yellow ferric oxide (10 mg and 2 mg), red ferric oxide (2 mg, 4 mg, 6 mg, 8 mg), black ferric oxide (8 mg), and FD&C Blue No. 2 (indigo carmine) aluminum lake (10 mg and 12 mg). Oral Suspension. FYCOMPA oral suspension is a white to off-white opaque liquid providing perampanel in a concentration of 0.5 mg/mL. The oral suspension contains the following inactive ingredients: sorbitol, microcrystalline cellulose, carboxymethyl-cellulose sodium, poloxamer, simethicone, citric acid, sodium benzoate and purified water.</Description>
</NDC>
<NDC>
<NDCCode>62856-583-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14) </PackageDescription>
<NDC11Code>62856-0583-14</NDC11Code>
<ProductNDC>62856-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Banzel</ProprietaryName>
<NonProprietaryName>Rufinamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021911</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>RUFINAMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180808</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.</IndicationAndUsage>
<Description>BANZEL (rufinamide) is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide has the chemical name 1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide. It has an empirical formula of C10H8F2N4O and a molecular weight of 238.2. The drug substance is a white, crystalline, odorless, and slightly bitter tasting neutral powder. Rufinamide is practically insoluble in water, slightly soluble in tetrahydrofuran and in methanol, and very slightly soluble in ethanol and in acetonitrile. BANZEL is available for oral administration in film-coated tablets, scored on both sides, containing 200 and 400 mg of rufinamide. Inactive ingredients are colloidal silicon dioxide, corn starch crosscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate. The film coating contains hypromellose, iron oxide red, polyethylene glycol, talc, and titanium dioxide. BANZEL is also available for oral administration as a liquid containing rufinamide at a concentration of 40 mg/mL. Inactive ingredients include microcrystalline cellulose and carboxymethylcellulose sodium, hydroxyethylcellulose, anhydrous citric acid, simethicone emulsion 30%, poloxamer 188, methylparaben, propylparaben, propylene glycol, potassium sorbate, noncrystallizing sorbitol solution 70%, and an orange flavor.</Description>
</NDC>
<NDC>
<NDCCode>10544-270-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (10544-270-14)</PackageDescription>
<NDC11Code>10544-0270-14</NDC11Code>
<ProductNDC>10544-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070044</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets, USP 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, USP 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, USP in cases of reinfection. Amebiasis. Metronidazole tablets, USP 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 USP 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, USP. 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, USP and other antibacterial drugs, metronidazole tablets, USP 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, USP, 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 250 mg and 500 mg tablets, USP, for oral administration, contain the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>13733-270-01</NDCCode>
<PackageDescription>14 g in 1 CARTON (13733-270-01)</PackageDescription>
<NDC11Code>13733-0270-01</NDC11Code>
<ProductNDC>13733-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha The Original Tension Pact Perfect Cover Spf37 No 13</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide,</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Able C&C Co., Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>5; 12.6; 2.94</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>21695-270-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (21695-270-14)</PackageDescription>
<NDC11Code>21695-0270-14</NDC11Code>
<ProductNDC>21695-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040748</ApplicationNumber>
<LabelerName>Rebel Distributors Corp.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>7.5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46708-270-14</NDCCode>
<PackageDescription>126 CAPSULE in 1 CARTON (46708-270-14) </PackageDescription>
<NDC11Code>46708-0270-14</NDC11Code>
<ProductNDC>46708-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of celecoxib and other treatment options before deciding to use celecoxib. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>Celecoxib USP is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows. Celecoxib oral capsules contain either50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide and gelatin. Details of non-volatile components of the imprinting ink are given below. 50 mg capsule contains shellac, propylene glycol and red iron oxide. 100 mg capsule contains shellac, propylene glycol and FD & C Blue No. # 2 aluminum lake. 200 mg capsule contains shellac, propylene glycol and yellow iron oxide. 400 mg capsule contains shellac, propylene glycol, titanium dioxide, yellow iron oxide and FD & C Blue No. # 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>54340-270-14</NDCCode>
<PackageDescription>1356 g in 1 CELLO PACK (54340-270-14) </PackageDescription>
<NDC11Code>54340-0270-14</NDC11Code>
<ProductNDC>54340-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Complete Antibacterial Bar</ProprietaryName>
<ProprietaryNameSuffix>Spring Water</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210308</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. For washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54340-270-23</NDCCode>
<PackageDescription>4 CELLO PACK in 1 CARTON (54340-270-23) / 1356 g in 1 CELLO PACK (54340-270-14) </PackageDescription>
<NDC11Code>54340-0270-23</NDC11Code>
<ProductNDC>54340-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Complete Antibacterial Bar</ProprietaryName>
<ProprietaryNameSuffix>Spring Water</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210308</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. For washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-270-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-270-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0270-14</NDC11Code>
<ProductNDC>63776-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ithurts</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Apomorphine, Metenkefalin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; METENKEFALIN</SubstanceName>
<StrengthNumber>200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Dopaminergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help with inflammatory & pain symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67046-270-14</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BLISTER PACK (67046-270-14) </PackageDescription>
<NDC11Code>67046-0270-14</NDC11Code>
<ProductNDC>67046-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69716-270-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (69716-270-02) > 14 g in 1 BOTTLE, PLASTIC (69716-270-01) </PackageDescription>
<NDC11Code>69716-0270-02</NDC11Code>
<ProductNDC>69716-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nots Crystal Cc Cushion No 23</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NoTS Co.,Ltd</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>1.96; 1.05; .7</StrengthNumber>
<StrengthUnit>g/14g; g/14g; g/14g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-270-14</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69842-270-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0270-14</NDC11Code>
<ProductNDC>69842-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202194</ApplicationNumber>
<LabelerName>CVS Health Corp</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-270-28</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (69842-270-28) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0270-28</NDC11Code>
<ProductNDC>69842-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202194</ApplicationNumber>
<LabelerName>CVS Health Corp</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69842-270-42</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (69842-270-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>69842-0270-42</NDC11Code>
<ProductNDC>69842-270</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202194</ApplicationNumber>
<LabelerName>CVS Health Corp</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72789-270-14</NDCCode>
<PackageDescription>14 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-14) </PackageDescription>
<NDC11Code>72789-0270-14</NDC11Code>
<ProductNDC>72789-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070308</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073652</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin Capsules USP (Macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiellaand Enterobacterspecies. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (Macrocrystals) 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules USP (Macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules USP (Macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules USP (Macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin Capsules, USP (Macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Capsules, USP (Macrocrystals) are an antibacterial agent for specific urinary tract infections. Nitrofurantoin, USP (macrocrystals) is chemically designated as 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]amino]- and has the following structural formula. C 8H 6N 4O 5(anhydrous) M.W. 238.16. Each capsule, for oral administration, contains 50 mg or 100 mg of nitrofurantoin, USP (macrocrystals). In addition, each capsule contains the following inactive ingredients: corn starch, edible black ink (black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, shellac glaze), gelatin, lactose monohydrate, talc, titanium dioxide and colorant D&C Red No. 33.</Description>
</NDC>
<NDC>
<NDCCode>73069-270-14</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-270-14) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0270-14</NDC11Code>
<ProductNDC>73069-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-ithurts</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Apomorphine, Metenkefalin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; BETA-ENDORPHIN HUMAN</SubstanceName>
<StrengthNumber>201; 201; 201</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA],Dopaminergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>85766-270-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (85766-270-14) </PackageDescription>
<NDC11Code>85766-0270-14</NDC11Code>
<ProductNDC>85766-270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209553</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients ( 1.1) : 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir Tablets, USP is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, hypromellose, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone K90, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13H 20N 6O 4∙HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
</NDC>
<NDC>
<NDCCode>62856-405-10</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62856-0405-10</NDC11Code>
<ProductNDC>62856-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dayvigo</ProprietaryName>
<NonProprietaryName>Lemborexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212028</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>LEMBOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.</Description>
</NDC>
<NDC>
<NDCCode>62856-405-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) </PackageDescription>
<NDC11Code>62856-0405-30</NDC11Code>
<ProductNDC>62856-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dayvigo</ProprietaryName>
<NonProprietaryName>Lemborexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212028</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>LEMBOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.</Description>
</NDC>
<NDC>
<NDCCode>62856-405-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90) </PackageDescription>
<NDC11Code>62856-0405-90</NDC11Code>
<ProductNDC>62856-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dayvigo</ProprietaryName>
<NonProprietaryName>Lemborexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212028</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>LEMBOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.</Description>
</NDC>
<NDC>
<NDCCode>62856-410-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (62856-410-30) </PackageDescription>
<NDC11Code>62856-0410-30</NDC11Code>
<ProductNDC>62856-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dayvigo</ProprietaryName>
<NonProprietaryName>Lemborexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212028</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>LEMBOREXANT</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.</Description>
</NDC>
<NDC>
<NDCCode>62856-410-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (62856-410-90) </PackageDescription>
<NDC11Code>62856-0410-90</NDC11Code>
<ProductNDC>62856-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dayvigo</ProprietaryName>
<NonProprietaryName>Lemborexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212028</ApplicationNumber>
<LabelerName>Eisai Inc.</LabelerName>
<SubstanceName>LEMBOREXANT</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Orexin Receptor Antagonist [EPC], Orexin Receptor Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)].</IndicationAndUsage>
<Description>DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2. The molecular weight is 410.42. Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration. Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.</Description>
</NDC>
<NDC>
<NDCCode>0074-4456-04</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (0074-4456-04) </PackageDescription>
<NDC11Code>00074-4456-04</NDC11Code>
<ProductNDC>0074-4456</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultane</ProprietaryName>
<NonProprietaryName>Sevoflurane</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19950607</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020478</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>SEVOFLURANE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mL/250mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19950607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. ULTANE should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.</IndicationAndUsage>
<Description>ULTANE (sevoflurane), volatile liquid for inhalation, a nonflammable and nonexplosive liquid administered by vaporization, is a halogenated general inhalation anesthetic drug. Sevoflurane is fluoromethyl 2,2,2,-trifluoro-1-(trifluoromethyl) ethyl ether and its structural formula is:. Sevoflurane is nonflammable and nonexplosive as defined by the requirements of International Electrotechnical Commission 601-2-13. Sevoflurane is a clear, colorless, liquid containing no additives. Sevoflurane is not corrosive to stainless steel, brass, aluminum, nickel-plated brass, chrome-plated brass or copper beryllium. Sevoflurane is nonpungent. It is miscible with ethanol, ether, chloroform, and benzene, and it is slightly soluble in water. Sevoflurane is stable when stored under normal room lighting conditions according to instructions. No discernible degradation of sevoflurane occurs in the presence of strong acids or heat. When in contact with alkaline CO2 absorbents (e.g., Baralyme® and to a lesser extent soda lime) within the anesthesia machine, sevoflurane can undergo degradation under certain conditions. Degradation of sevoflurane is minimal, and degradants are either undetectable or present in non-toxic amounts when used as directed with fresh absorbents. Sevoflurane degradation and subsequent degradant formation are enhanced by increasing absorbent temperature increased sevoflurane concentration, decreased fresh gas flow and desiccated CO2 absorbents (especially with potassium hydroxide containing absorbents e.g., Baralyme). Sevoflurane alkaline degradation occurs by two pathways. The first results from the loss of hydrogen fluoride with the formation of pentafluoroisopropenyl fluoromethyl ether, (PIFE, C4H2F6O), also known as Compound A, and trace amounts of pentafluoromethoxy isopropyl fluoromethyl ether, (PMFE, C5H6F6O), also known as Compound B. The second pathway for degradation of sevoflurane, which occurs primarily in the presence of desiccated CO2 absorbents, is discussed later. In the first pathway, the defluorination pathway, the production of degradants in the anesthesia circuit results from the extraction of the acidic proton in the presence of a strong base (KOH and/or NaOH) forming an alkene (Compound A) from sevoflurane similar to formation of 2-bromo-2-chloro-1,1-difluoro ethylene (BCDFE) from halothane. Laboratory simulations have shown that the concentration of these degradants is inversely correlated with the fresh gas flow rate (See Figure 1). Since the reaction of carbon dioxide with absorbents is exothermic, the temperature increase will be determined by quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anesthesia circle system, metabolic status of the patient, and ventilation. The relationship of temperature produced by varying levels of CO2 and Compound A production is illustrated in the following in vitro simulation where CO2 was added to a circle absorber system. Compound A concentration in a circle absorber system increases as a function of increasing CO2 absorbent temperature and composition (Baralyme producing higher levels than soda lime), increased body temperature, and increased minute ventilation, and decreasing fresh gas flow rates. It has been reported that the concentration of Compound A increases significantly with prolonged dehydration of Baralyme. Compound A exposure in patients also has been shown to rise with increased sevoflurane concentrations and duration of anesthesia. In a clinical study in which sevoflurane was administered to patients under low flow conditions for ≥ 2 hours at flow rates of 1 Liter/minute, Compound A levels were measured in an effort to determine the relationship between MAC hours and Compound A levels produced. The relationship between Compound A levels and sevoflurane exposure are shown in Figure 2a. Compound A has been shown to be nephrotoxic in rats after exposures that have varied in duration from one to three hours. No histopathologic change was seen at a concentration of up to 270 ppm for one hour. Sporadic single cell necrosis of proximal tubule cells has been reported at a concentration of 114 ppm after a 3-hour exposure to Compound A in rats. The LC50 reported at 1 hour is 1050-1090 ppm (male-female) and, at 3 hours, 350-490 ppm (male-female). An experiment was performed comparing sevoflurane plus 75 or 100 ppm Compound A with an active control to evaluate the potential nephrotoxicity of Compound A in non-human primates. A single 8-hour exposure of Sevoflurane in the presence of Compound A produced single-cell renal tubular degeneration and single-cell necrosis in cynomolgus monkeys. These changes are consistent with the increased urinary protein, glucose level and enzymic activity noted on days one and three on the clinical pathology evaluation. This nephrotoxicity produced by Compound A is dose and duration of exposure dependent. At a fresh gas flow rate of 1 L/min, mean maximum concentrations of Compound A in the anesthesia circuit in clinical settings are approximately 20 ppm (0.002%) with soda lime and 30 ppm (0.003%) with Baralyme in adult patients; mean maximum concentrations in pediatric patients with soda lime are about half those found in adults. The highest concentration observed in a single patient with Baralyme was 61 ppm (0.0061%) and 32 ppm (0.0032%) with soda lime. The levels of Compound A at which toxicity occurs in humans is not known. The second pathway for degradation of sevoflurane occurs primarily in the presence of desiccated CO2 absorbents and leads to the dissociation of sevoflurane into hexafluoroisopropanol (HFIP) and formaldehyde. HFIP is inactive, non-genotoxic, rapidly glucuronidated and cleared by the liver. Formaldehyde is present during normal metabolic processes. Upon exposure to a highly desiccated absorbent, formaldehyde can further degrade into methanol and formate. Formate can contribute to the formation of carbon monoxide in the presence of high temperature that can be associated with desiccated Baralyme®. Methanol can react with Compound A to form the methoxy addition product Compound B. Compound B can undergo further HF elimination to form Compounds C, D, and E. Sevoflurane degradants were observed in the respiratory circuit of an experimental anesthesia machine using desiccated CO2 absorbents and maximum sevoflurane concentrations (8%) for extended periods of time (> 2 hours). Concentrations of formaldehyde observed with desiccated soda lime in this experimental anesthesia respiratory circuit were consistent with levels that could potentially result in respiratory irritation. Although KOH containing CO2 absorbents are no longer commercially available, in the laboratory experiments, exposure of sevoflurane to the desiccated KOH containing CO2 absorbent, Baralyme, resulted in the detection of substantially greater degradant levels.</Description>
</NDC>
<NDC>
<NDCCode>0115-1565-44</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 CARTON (0115-1565-44) </PackageDescription>
<NDC11Code>00115-1565-44</NDC11Code>
<ProductNDC>0115-1565</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209677</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4-trifluoromethylphenyl)-amide. Its molecular weight is 270.21, and the empirical formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 14 mg of teriflunomide and the following inactive ingredients: lactose monohydrate, hydroxypropylcellulose, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The film coating for the 14 mg tablet is made of titanium dioxide, talcum, hypromellose, cottonseed oil and FD&C Blue no. 2 Al-Lake and FD&C Red No. 40.</Description>
</NDC>
<NDC>
<NDCCode>0378-0627-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0627-93) </PackageDescription>
<NDC11Code>00378-0627-93</NDC11Code>
<ProductNDC>0378-0627</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
<NonProprietaryName>Teriflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209702</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-α,α,α-trifluoro-3-hydroxy-4-crotonotoluidide. Its molecular weight is 270.21, and the molecular formula is C12 H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide. The 7 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake and the 14 mg tablets also contain red iron oxide and yellow iron oxide.</Description>
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<NDCCode>0378-0628-93</NDCCode>
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<ProductNDC>0378-0628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriflunomide</ProprietaryName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-01</LastUpdate>
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<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-Cyano-α,α,α-trifluoro-3-hydroxy-4-crotonotoluidide. Its molecular weight is 270.21, and the molecular formula is C12 H9F3N2O2 with the following chemical structure. Teriflunomide is a white to almost white powder that is sparingly soluble in acetone, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate (potato) and titanium dioxide. The 7 mg tablets also contain FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake and the 14 mg tablets also contain red iron oxide and yellow iron oxide.</Description>
</NDC>
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<NDCCode>0480-3156-56</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0480-3156-56) </PackageDescription>
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<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TERIFLUNOMIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2026-09-11</LastUpdate>
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<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
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<NDCCode>0480-3157-56</NDCCode>
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<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriflunomide tablets are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.</IndicationAndUsage>
<Description>Teriflunomide is an oral de novo pyrimidine synthesis inhibitor of the DHO-DH enzyme, with the chemical name (Z)-2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide. Its molecular weight is 270.21, and the molecular formula is C12H9F3N2O2 with the following chemical structure. Teriflunomide is a white crystalline powder that is sparingly soluble in acetone and ethyl acetate, slightly soluble in polyethylene glycol and ethanol, very slightly soluble in isopropanol and methanol and practically insoluble in water. Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide tablets contain 7 mg or 14 mg of teriflunomide and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2/Indigo Carmine Aluminum Lake, hydroxypropyl cellulose, hypromellose 2910, lactose monohydrate, maize starch, microcrystalline cellulose, polyethylene glycol 8000, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide. In addition, the 7 mg tablet contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.</Description>
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