{
"NDC": [
{
"NDCCode": "61307-056-31",
"PackageDescription": "1500 mL in 1 BOTTLE (61307-056-31) ",
"NDC11Code": "61307-0056-31",
"ProductNDC": "61307-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing Gel",
"NonProprietaryName": "Instant Hand Sanitizing Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130507",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130507",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease, Recommended for repeated use."
},
{
"NDCCode": "61307-017-31",
"PackageDescription": "1500 mL in 1 BOTTLE (61307-017-31) ",
"NDC11Code": "61307-0017-31",
"ProductNDC": "61307-017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E2 Hand Sanitizer",
"NonProprietaryName": "E2 Hand Sanitizer",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".013",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151210",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For hand washing to decrease bacteria on skin."
},
{
"NDCCode": "43419-056-31",
"PackageDescription": "2 CONTAINER in 1 CARTON (43419-056-31) > 15 g in 1 CONTAINER",
"NDC11Code": "43419-0056-31",
"ProductNDC": "43419-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sulwhasoo Perpecting Cushion Brightening No.17 Light Beige",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160411",
"EndMarketingDate": "20220312",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "2.1; 1.245; 2.94",
"StrengthUnit": "g/30g; g/30g; g/30g",
"Status": "Deprecated",
"LastUpdate": "2022-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160411",
"EndMarketingDatePackage": "20220312",
"SamplePackage": "N"
},
{
"NDCCode": "62331-056-31",
"PackageDescription": "25 kg in 1 DRUM (62331-056-31) ",
"NDC11Code": "62331-0056-31",
"ProductNDC": "62331-056",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "POWDER",
"StartMarketingDate": "20121121",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Divi's Laboratories Limited",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-08-05",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "21-NOV-12"
},
{
"NDCCode": "62332-056-31",
"PackageDescription": "100 TABLET in 1 BOTTLE (62332-056-31) ",
"NDC11Code": "62332-0056-31",
"ProductNDC": "62332-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091368",
"LabelerName": "Alembic Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160503",
"SamplePackage": "N",
"IndicationAndUsage": "Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.",
"Description": "Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate and FD&C Yellow No. 6 Aluminum Lake. Clonidine hydrochloride 0.1 mg tablets also contain FD&C Red No. 40 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. C9H9Cl2N3.HCl Mol Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol."
},
{
"NDCCode": "30142-056-67",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (30142-056-67) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "30142-0056-67",
"ProductNDC": "30142-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20140621",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140621",
"SamplePackage": "N"
},
{
"NDCCode": "60933-056-00",
"PackageDescription": "3790 mL in 1 BOTTLE (60933-056-00) ",
"NDC11Code": "60933-0056-00",
"ProductNDC": "60933-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Franklin Cleaning Technology Antibacterial Hand",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230428",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Fuller Industries, Inc",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230428",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease the bacteria on skin. Recommended for repeated use."
},
{
"NDCCode": "69766-056-01",
"PackageDescription": "50 kg in 1 DRUM (69766-056-01) ",
"NDC11Code": "69766-0056-01",
"ProductNDC": "69766-056",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pimavanserin Tartrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20181031",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "MSN Life Sciences Private Limited",
"SubstanceName": "PIMAVANSERIN TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-14",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "31-OCT-18"
},
{
"NDCCode": "70594-056-02",
"PackageDescription": "6 BAG in 1 CARTON (70594-056-02) / 150 mL in 1 BAG (70594-056-01) ",
"NDC11Code": "70594-0056-02",
"ProductNDC": "70594-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200513",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Xellia Pharmaceuticals USA LLC",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/150mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200513",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "Vancomycin Injection, USP, in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24∙HCl and the molecular weight is 1,485.71. The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula. Vancomycin Injection, USP, in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
"NDCCode": "70594-056-03",
"PackageDescription": "12 BAG in 1 CARTON (70594-056-03) / 150 mL in 1 BAG (70594-056-01) ",
"NDC11Code": "70594-0056-03",
"ProductNDC": "70594-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200513",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Xellia Pharmaceuticals USA LLC",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/150mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200513",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "Vancomycin Injection, USP, in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24∙HCl and the molecular weight is 1,485.71. The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula. Vancomycin Injection, USP, in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
"NDCCode": "72578-056-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (72578-056-01) ",
"NDC11Code": "72578-0056-01",
"ProductNDC": "72578-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200303",
"SamplePackage": "N",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake."
},
{
"NDCCode": "72578-056-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (72578-056-05) ",
"NDC11Code": "72578-0056-05",
"ProductNDC": "72578-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200303",
"SamplePackage": "N",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake."
},
{
"NDCCode": "72578-056-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (72578-056-06) ",
"NDC11Code": "72578-0056-06",
"ProductNDC": "72578-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200303",
"SamplePackage": "N",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake."
},
{
"NDCCode": "72578-056-16",
"PackageDescription": "90 TABLET in 1 BOTTLE (72578-056-16) ",
"NDC11Code": "72578-0056-16",
"ProductNDC": "72578-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200303",
"SamplePackage": "N",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake."
},
{
"NDCCode": "72578-056-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (72578-056-77) / 10 TABLET in 1 BLISTER PACK (72578-056-30) ",
"NDC11Code": "72578-0056-77",
"ProductNDC": "72578-056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Felbamate",
"NonProprietaryName": "Felbamate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208970",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "FELBAMATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200303",
"SamplePackage": "N",
"IndicationAndUsage": "Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.",
"Description": "Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake."
},
{
"NDCCode": "84525-056-03",
"PackageDescription": "30 g in 1 BOX (84525-056-03) ",
"NDC11Code": "84525-0056-03",
"ProductNDC": "84525-056",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Retionl Collagen",
"NonProprietaryName": "Trstay Retionl Collagen",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240828",
"EndMarketingDate": "20310829",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Guangzhou Lifubao Cocmetics Co., Ltd.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240828",
"EndMarketingDatePackage": "20310829",
"SamplePackage": "N"
},
{
"NDCCode": "61307-017-09",
"PackageDescription": "3785 mL in 1 BOTTLE (61307-017-09) ",
"NDC11Code": "61307-0017-09",
"ProductNDC": "61307-017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E2 Hand Sanitizer",
"NonProprietaryName": "E2 Hand Sanitizer",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".013",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20151210",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For hand washing to decrease bacteria on skin."
},
{
"NDCCode": "61307-060-09",
"PackageDescription": "3785 mL in 1 BOTTLE (61307-060-09) ",
"NDC11Code": "61307-0060-09",
"ProductNDC": "61307-060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand",
"NonProprietaryName": "Antiseptic Hand Soap",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": ".3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Handwash to help decrease bacteria on the skin."
},
{
"NDCCode": "61307-105-10",
"PackageDescription": "3790 mL in 1 BOTTLE (61307-105-10) ",
"NDC11Code": "61307-0105-10",
"ProductNDC": "61307-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Hand Sanitizer Foam",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200610",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200610",
"SamplePackage": "N",
"IndicationAndUsage": " Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "61307-106-10",
"PackageDescription": "3.79 L in 1 BOTTLE (61307-106-10) ",
"NDC11Code": "61307-0106-10",
"ProductNDC": "61307-106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "620",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2021-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200701",
"SamplePackage": "N"
},
{
"NDCCode": "61307-213-10",
"PackageDescription": "1 L in 1 BAG (61307-213-10) ",
"NDC11Code": "61307-0213-10",
"ProductNDC": "61307-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indulgence/propower",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "U S Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/L",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin."
},
{
"NDCCode": "61307-213-41",
"PackageDescription": "1 L in 1 BAG (61307-213-41) ",
"NDC11Code": "61307-0213-41",
"ProductNDC": "61307-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Indulgence/propower",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "U S Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/L",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin."
},
{
"NDCCode": "61307-640-10",
"PackageDescription": "1000 mL in 1 BAG (61307-640-10) ",
"NDC11Code": "61307-0640-10",
"ProductNDC": "61307-640",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Antibacterial Hand",
"NonProprietaryName": "Lavish Antibacterial",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181028",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".013",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181028",
"SamplePackage": "N",
"IndicationAndUsage": "Uses For handwashing to decrease bacteria on skin."
},
{
"NDCCode": "61307-688-10",
"PackageDescription": "1000 mL in 1 BAG (61307-688-10) ",
"NDC11Code": "61307-0688-10",
"ProductNDC": "61307-688",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Foaming Hand Sanitizer",
"NonProprietaryName": "Indulgence Hand Sanitizer",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120703",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "US Chemical Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120703",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Hand sanitizer to help reduce bacteria on the skin that could cause diease. Recommended for repeated use."
},
{
"NDCCode": "0069-0238-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0238-01) / 10 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00069-0238-01",
"ProductNDC": "0069-0238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ruxience",
"NonProprietaryName": "Rituximab-pvvr",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761103",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N",
"IndicationAndUsage": "RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
"Description": "Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "0069-0249-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "00069-0249-01",
"ProductNDC": "0069-0249",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ruxience",
"NonProprietaryName": "Rituximab-pvvr",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761103",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "RITUXIMAB",
"StrengthNumber": "500",
"StrengthUnit": "mg/50mL",
"Pharm_Classes": "CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N",
"IndicationAndUsage": "RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).",
"Description": "Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8."
},
{
"NDCCode": "0378-0630-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0378-0630-01) ",
"NDC11Code": "00378-0630-01",
"ProductNDC": "0378-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
},
{
"NDCCode": "0378-0630-88",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0378-0630-88) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "00378-0630-88",
"ProductNDC": "0378-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
},
{
"NDCCode": "0378-0630-91",
"PackageDescription": "60 TABLET in 1 BOTTLE (0378-0630-91) ",
"NDC11Code": "00378-0630-91",
"ProductNDC": "0378-0630",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170320",
"SamplePackage": "N",
"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
},
{
"NDCCode": "0378-0631-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0378-0631-01) ",
"NDC11Code": "00378-0631-01",
"ProductNDC": "0378-0631",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iloperidone",
"NonProprietaryName": "Iloperidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207231",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ILOPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-15",
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"StartMarketingDatePackage": "20170320",
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"IndicationAndUsage": "Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .",
"Description": "Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with \"050\",\"051\",\"052\",\"053\",\"054\",\"055\",or \"056\"on one side and plain on other side."
}
]
}
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<NDC11Code>62332-0056-31</NDC11Code>
<ProductNDC>62332-056</ProductNDC>
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<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091368</ApplicationNumber>
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<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
<Description>Clonidine hydrochloride is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate and FD&C Yellow No. 6 Aluminum Lake. Clonidine hydrochloride 0.1 mg tablets also contain FD&C Red No. 40 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:. C9H9Cl2N3.HCl Mol Wt. 266.56. Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.</Description>
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<PackageDescription>24 BLISTER PACK in 1 CARTON (30142-056-67) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>30142-056</ProductNDC>
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<ProprietaryName>Nighttime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2023-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>60933-056-00</NDCCode>
<PackageDescription>3790 mL in 1 BOTTLE (60933-056-00) </PackageDescription>
<NDC11Code>60933-0056-00</NDC11Code>
<ProductNDC>60933-056</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Franklin Cleaning Technology Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230428</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Fuller Industries, Inc</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease the bacteria on skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
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<NDCCode>69766-056-01</NDCCode>
<PackageDescription>50 kg in 1 DRUM (69766-056-01) </PackageDescription>
<NDC11Code>69766-0056-01</NDC11Code>
<ProductNDC>69766-056</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pimavanserin Tartrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
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<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>MSN Life Sciences Private Limited</LabelerName>
<SubstanceName>PIMAVANSERIN TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-14</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-OCT-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70594-056-02</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (70594-056-02) / 150 mL in 1 BAG (70594-056-01) </PackageDescription>
<NDC11Code>70594-0056-02</NDC11Code>
<ProductNDC>70594-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200513</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Xellia Pharmaceuticals USA LLC</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/150mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>Vancomycin Injection, USP, in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24∙HCl and the molecular weight is 1,485.71. The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula. Vancomycin Injection, USP, in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>70594-056-03</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (70594-056-03) / 150 mL in 1 BAG (70594-056-01) </PackageDescription>
<NDC11Code>70594-0056-03</NDC11Code>
<ProductNDC>70594-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200513</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Xellia Pharmaceuticals USA LLC</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/150mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>Vancomycin Injection, USP, in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The molecular formula is C66H75Cl2N9O24∙HCl and the molecular weight is 1,485.71. The chemical name is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-{[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]-oxy}-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino]valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. Vancomycin hydrochloride has the following structural formula. Vancomycin Injection, USP, in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>72578-056-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (72578-056-01) </PackageDescription>
<NDC11Code>72578-0056-01</NDC11Code>
<ProductNDC>72578-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72578-056-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (72578-056-05) </PackageDescription>
<NDC11Code>72578-0056-05</NDC11Code>
<ProductNDC>72578-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72578-056-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (72578-056-06) </PackageDescription>
<NDC11Code>72578-0056-06</NDC11Code>
<ProductNDC>72578-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72578-056-16</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (72578-056-16) </PackageDescription>
<NDC11Code>72578-0056-16</NDC11Code>
<ProductNDC>72578-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72578-056-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (72578-056-77) / 10 TABLET in 1 BLISTER PACK (72578-056-30) </PackageDescription>
<NDC11Code>72578-0056-77</NDC11Code>
<ProductNDC>72578-056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Felbamate</ProprietaryName>
<NonProprietaryName>Felbamate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208970</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>FELBAMATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings). Felbamate tablets, USP are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.</IndicationAndUsage>
<Description>Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate, USP is white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water. Felbamate's molecular weight is 238.24, its molecular formula is C11H14N2O4 and its structural formula is. Each felbamate tablet, USP contains felbamate, USP 400 mg or 600 mg and following inactive ingredients: colloidal silicon dioxide, ferric oxide yellow, FD & C red no. 40 aluminum lake, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone K 30, pregelatinised starch (botanical source: corn) and sodium starch glycolate type A (botanical source: potato). Apart from this felbamate tablets USP, 600 mg also contain D & C yellow no. 10 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>84525-056-03</NDCCode>
<PackageDescription>30 g in 1 BOX (84525-056-03) </PackageDescription>
<NDC11Code>84525-0056-03</NDC11Code>
<ProductNDC>84525-056</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Retionl Collagen</ProprietaryName>
<NonProprietaryName>Trstay Retionl Collagen</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240828</StartMarketingDate>
<EndMarketingDate>20310829</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Guangzhou Lifubao Cocmetics Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240828</StartMarketingDatePackage>
<EndMarketingDatePackage>20310829</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61307-017-09</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE (61307-017-09) </PackageDescription>
<NDC11Code>61307-0017-09</NDC11Code>
<ProductNDC>61307-017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E2 Hand Sanitizer</ProprietaryName>
<NonProprietaryName>E2 Hand Sanitizer</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>US Chemical Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.013</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For hand washing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61307-060-09</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE (61307-060-09) </PackageDescription>
<NDC11Code>61307-0060-09</NDC11Code>
<ProductNDC>61307-060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Antiseptic Hand Soap</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>US Chemical Corporation</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Handwash to help decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61307-105-10</NDCCode>
<PackageDescription>3790 mL in 1 BOTTLE (61307-105-10) </PackageDescription>
<NDC11Code>61307-0105-10</NDC11Code>
<ProductNDC>61307-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Hand Sanitizer Foam</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>US Chemical Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61307-106-10</NDCCode>
<PackageDescription>3.79 L in 1 BOTTLE (61307-106-10) </PackageDescription>
<NDC11Code>61307-0106-10</NDC11Code>
<ProductNDC>61307-106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>US Chemical Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>620</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61307-213-10</NDCCode>
<PackageDescription>1 L in 1 BAG (61307-213-10) </PackageDescription>
<NDC11Code>61307-0213-10</NDC11Code>
<ProductNDC>61307-213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indulgence/propower</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>U S Chemical Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61307-213-41</NDCCode>
<PackageDescription>1 L in 1 BAG (61307-213-41) </PackageDescription>
<NDC11Code>61307-0213-41</NDC11Code>
<ProductNDC>61307-213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Indulgence/propower</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>U S Chemical Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61307-640-10</NDCCode>
<PackageDescription>1000 mL in 1 BAG (61307-640-10) </PackageDescription>
<NDC11Code>61307-0640-10</NDC11Code>
<ProductNDC>61307-640</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Antibacterial Hand</ProprietaryName>
<NonProprietaryName>Lavish Antibacterial</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181028</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>US Chemical Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.013</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses For handwashing to decrease bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61307-688-10</NDCCode>
<PackageDescription>1000 mL in 1 BAG (61307-688-10) </PackageDescription>
<NDC11Code>61307-0688-10</NDC11Code>
<ProductNDC>61307-688</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Foaming Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Indulgence Hand Sanitizer</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120703</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>US Chemical Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Hand sanitizer to help reduce bacteria on the skin that could cause diease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0238-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0069-0238-01) / 10 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00069-0238-01</NDC11Code>
<ProductNDC>0069-0238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ruxience</ProprietaryName>
<NonProprietaryName>Rituximab-pvvr</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761103</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
<Description>Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8.</Description>
</NDC>
<NDC>
<NDCCode>0069-0249-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0069-0249-01) / 50 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00069-0249-01</NDC11Code>
<ProductNDC>0069-0249</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ruxience</ProprietaryName>
<NonProprietaryName>Rituximab-pvvr</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761103</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>RITUXIMAB</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/50mL</StrengthUnit>
<Pharm_Classes>CD20-directed Antibody Interactions [MoA], CD20-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RUXIENCE is a CD20-directed cytolytic antibody indicated for the treatment of: 1 Adult patients with Non-Hodgkin's Lymphoma (NHL) (1.1).oRelapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent.oPreviously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.oNon-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.oPreviously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens., 2 Adult patients with Chronic Lymphocytic Leukemia (CLL) (1.2).oPreviously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)., 3 Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to-severely-active RA who have inadequate response to one or more TNF antagonist therapies (1.3)., 4 Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids (1.4)., 5 Moderate to severe Pemphigus Vulgaris (PV) in adult patients (1.5).</IndicationAndUsage>
<Description>Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium. RUXIENCE (rituximab-pvvr) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale brownish-yellow solution for intravenous infusion. RUXIENCE is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Each mL of solution contains 10 mg rituximab-pvvr, 0.056 mg of edetate disodium dihydrate, 1.2 mg of L-histidine, 2.57 mg of L-histidine hydrochloride monohydrate, 0.2 mg of polysorbate 80, 85 mg of sucrose, and Water for Injection, USP. The pH is 5.8.</Description>
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<NDCCode>0378-0630-01</NDCCode>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iloperidone</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207231</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
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<NDC>
<NDCCode>0378-0630-88</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0378-0630-88) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-0630-88</NDC11Code>
<ProductNDC>0378-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
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<NDC>
<NDCCode>0378-0630-91</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0378-0630-91) </PackageDescription>
<NDC11Code>00378-0630-91</NDC11Code>
<ProductNDC>0378-0630</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iloperidone</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207231</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
</NDC>
<NDC>
<NDCCode>0378-0631-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0378-0631-01) </PackageDescription>
<NDC11Code>00378-0631-01</NDC11Code>
<ProductNDC>0378-0631</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iloperidone</ProprietaryName>
<NonProprietaryName>Iloperidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207231</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ILOPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iloperidone tablets is indicated for: 1 Treatment of schizophrenia in adults [see Clinical Studies ( 14.1)]. .</IndicationAndUsage>
<Description>Iloperidone is an atypical antipsychotic belonging to the chemical class of piperidinyl-benzisoxazole derivatives. Its chemical name is 4'-[3-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]propoxy]-3'-methoxyacetophenone. Its molecular formula is C 24H 27FN 2O 4and its molecular weight is 426.48. The structural formula is:. Iloperidone is a white to off-white finely crystalline powder. It is practically insoluble in water, very slightly soluble in 0.1 N HCl and freely soluble in chloroform, ethanol, methanol, and acetonitrile. Iloperidone tablets are intended for oral administration only. Each round, uncoated tablet contains 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg of iloperidone. Inactive ingredients are: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate and purified water (removed during processing). The tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050","051","052","053","054","055",or "056"on one side and plain on other side.</Description>
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