{
"NDC": [
{
"NDCCode": "41520-055-43",
"PackageDescription": "454 g in 1 POUCH (41520-055-43)",
"NDC11Code": "41520-0055-43",
"ProductNDC": "41520-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Epsom Salt",
"NonProprietaryName": "Magnesium Sulfate",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20150506",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "FOODHOLD U.S.A., LLC",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "41520-055-07",
"PackageDescription": "1814 g in 1 POUCH (41520-055-07)",
"NDC11Code": "41520-0055-07",
"ProductNDC": "41520-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Epsom Salt",
"NonProprietaryName": "Magnesium Sulfate",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20150506",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "FOODHOLD U.S.A., LLC",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours."
},
{
"NDCCode": "37808-055-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (37808-055-43) ",
"NDC11Code": "37808-0055-43",
"ProductNDC": "37808-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150313",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "H E B",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "50",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150313",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent the risk of infection in: 1 minor cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "41520-435-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-435-43) ",
"NDC11Code": "41520-0435-43",
"ProductNDC": "41520-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anticavity",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Foodhold U.S.As., LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150628",
"SamplePackage": "N"
},
{
"NDCCode": "41520-804-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-804-43) ",
"NDC11Code": "41520-0804-43",
"ProductNDC": "41520-804",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150308",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FOODHOLD U.S.A., LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": ".91",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150308",
"SamplePackage": "N"
},
{
"NDCCode": "41520-810-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-810-43) ",
"NDC11Code": "41520-0810-43",
"ProductNDC": "41520-810",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "70%",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Foodhold U.S.A. LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N"
},
{
"NDCCode": "41520-822-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-822-43) ",
"NDC11Code": "41520-0822-43",
"ProductNDC": "41520-822",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Witch Hazel",
"NonProprietaryName": "Witch Hazel",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150324",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "ADUSA Distribution, LLC",
"SubstanceName": "WITCH HAZEL",
"StrengthNumber": "860",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150324",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of minor skin irritations due to: 1 insect bites, 2 minor cuts, 3 minor scrapes."
},
{
"NDCCode": "41520-845-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-845-43) ",
"NDC11Code": "41520-0845-43",
"ProductNDC": "41520-845",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Isopropyl Alcohol",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150407",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part344",
"LabelerName": "Foodhold U.S.A., LLC",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "613",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150407",
"SamplePackage": "N"
},
{
"NDCCode": "41520-877-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-877-43) ",
"NDC11Code": "41520-0877-43",
"ProductNDC": "41520-877",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mineral Oil",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "LIQUID",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20180709",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Foodhold U.S.A.",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "999",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180709",
"SamplePackage": "N"
},
{
"NDCCode": "41520-942-43",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (41520-942-43) ",
"NDC11Code": "41520-0942-43",
"ProductNDC": "41520-942",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111210",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "FOODHOLD U.S.A., LLC",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20111210",
"SamplePackage": "N"
},
{
"NDCCode": "23155-345-43",
"PackageDescription": "10 VIAL in 1 CARTON (23155-345-43) / 100 mL in 1 VIAL (23155-345-33) ",
"NDC11Code": "23155-0345-43",
"ProductNDC": "23155-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20211012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250602",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.",
"Description": "Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5."
},
{
"NDCCode": "43598-055-04",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (43598-055-04) ",
"NDC11Code": "43598-0055-04",
"ProductNDC": "43598-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nilotinib",
"NonProprietaryName": "Nilotinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20251119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218350",
"LabelerName": "Dr. Reddy's Laboratories Inc",
"SubstanceName": "NILOTINIB HYDROCHLORIDE MONOHYDRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251119",
"SamplePackage": "N",
"IndicationAndUsage": "Nilotinib is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2), 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .",
"Description": "Nilotinib capsules contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of hydrochloride monohydrate, is a white or slightly yellowish or slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H25ClF3N7O2 and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). Freely soluble in dimethyl sulphoxide. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa value of nilotinib hydrochloride monohydrate is found to be 5.64. The chemical name of nilotinib hydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Nilotinib capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55.14 mg, 165.43 mg, and 220.57 mg nilotinib hydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer 188. The 50 mg and 150 mg capsules contain gelatin, iron oxide (red), iron oxide (yellow), sodium lauryl sulphate and titanium dioxide. The 200 mg capsules contain gelatin, iron oxide (yellow), sodium lauryl sulphate and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "50881-055-08",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-055-08) ",
"NDC11Code": "50881-0055-08",
"ProductNDC": "50881-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jakafi Xr",
"NonProprietaryName": "Ruxolitinib",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217180",
"LabelerName": "Incyte Corporation",
"SubstanceName": "RUXOLITINIB",
"StrengthNumber": "55",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: 1 intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. (1.1), 2 polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. (1.2), 3 steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. (1.3), 4 chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. (1.4).",
"Description": "Ruxolitinib phosphate is a kinase inhibitor with the chemical name (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36. Ruxolitinib phosphate has the following structural formula. Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8. JAKAFI (ruxolitinib) tablets are for oral administration. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of ruxolitinib free base, equivalent to 6.6 mg, 13.2 mg, 19.8 mg, 26.4 mg, or 33 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. JAKAFI XR (ruxolitinib) extended-release tablets are for oral administration. Each tablet contains 11 mg, 22 mg, 33 mg, 44 mg, or 55 mg of ruxolitinib free base equivalent to 14.5 mg, 29 mg, 43.6 mg, 58.1 mg, or 72.6 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: colorants (black iron oxide, red iron oxide, and yellow iron oxide), copovidone, hypromellose, polydextrose, polyethylene glycol, titanium dioxide, and triglycerides."
},
{
"NDCCode": "63323-269-94",
"PackageDescription": "10 VIAL in 1 BOX (63323-269-94) / 20 mL in 1 VIAL (63323-269-43) ",
"NDC11Code": "63323-0269-94",
"ProductNDC": "63323-269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diprivan",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019627",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091113",
"SamplePackage": "N",
"IndicationAndUsage": "DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.",
"Description": "DIPRIVAN® (propofol) injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of DIPRIVAN® (Propofol) injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. DIPRIVAN is isotonic and has a pH of 7 to 8.5."
},
{
"NDCCode": "82868-055-21",
"PackageDescription": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-055-21) ",
"NDC11Code": "82868-0055-21",
"ProductNDC": "82868-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078518",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-07-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240530",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1–infected patientsReduction of transmission, 3 Herpes Zoster.",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride, USP (hydrous), which are equivalent to 500 mg or 1 gram of valacyclovir, on the anhydrous basis, respectively, and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. The white, film-coated tablets are printed with edible black ink which contains black iron oxide, propylene glycol and shellac glaze. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP (hydrous) is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 7.47 and 9.43. Meets USP Dissolution Test 2."
},
{
"NDCCode": "83634-603-51",
"PackageDescription": "10 VIAL in 1 CARTON (83634-603-51) / 100 mL in 1 VIAL (83634-603-43) ",
"NDC11Code": "83634-0603-51",
"ProductNDC": "83634-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "Avenacy, LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5."
},
{
"NDCCode": "41520-976-03",
"PackageDescription": "1 g in 1 CONTAINER (41520-976-03)",
"NDC11Code": "41520-0976-03",
"ProductNDC": "41520-976",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Care One Medicated Lip Balm In A Pot",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130312",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "American Sales Company",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "43.75",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Helps prevent and temporarily protect dry and chapped lips."
},
{
"NDCCode": "0069-0209-10",
"PackageDescription": "10 VIAL in 1 CARTON (0069-0209-10) / 20 mL in 1 VIAL (0069-0209-01) ",
"NDC11Code": "00069-0209-10",
"ProductNDC": "0069-0209",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205576",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerin (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5."
},
{
"NDCCode": "0069-0234-20",
"PackageDescription": "20 VIAL in 1 CARTON (0069-0234-20) / 50 mL in 1 VIAL",
"NDC11Code": "00069-0234-20",
"ProductNDC": "0069-0234",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205576",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerin (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5."
},
{
"NDCCode": "0069-0248-10",
"PackageDescription": "10 VIAL in 1 CARTON (0069-0248-10) / 100 mL in 1 VIAL",
"NDC11Code": "00069-0248-10",
"ProductNDC": "0069-0248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205576",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerin (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5."
},
{
"NDCCode": "0093-4147-56",
"PackageDescription": "30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00093-4147-56",
"ProductNDC": "0093-4147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levalbuterol",
"NonProprietaryName": "Levalbuterol",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20141216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200875",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141216",
"SamplePackage": "N",
"IndicationAndUsage": "Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "Levalbuterol Inhalation Solution USP (Concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride, USP is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol hydrochloride, USP is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol hydrochloride, USP is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol hydrochloride, USP is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP), 4 mg sodium chloride to adjust tonicity, and 0.055 mg edetate sodium dihydrate, 1 mg of trisodium citrate dihydrate, and sulfuric acid to adjust pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "0169-7810-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7810-01) * 4 mL in 1 VIAL, GLASS (0169-7811-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7810-01",
"ProductNDC": "0169-7810",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "0169-7815-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7815-01) * 4 mL in 1 VIAL, GLASS (0169-7855-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7815-01",
"ProductNDC": "0169-7815",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "0169-7820-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7820-01) * 4 mL in 1 VIAL, GLASS (0169-7821-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7820-01",
"ProductNDC": "0169-7820",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "0169-7825-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7825-01) * 4 mL in 1 VIAL, GLASS (0169-7829-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7825-01",
"ProductNDC": "0169-7825",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "0169-7830-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7830-01) * 4 mL in 1 VIAL, GLASS (0169-7831-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7830-01",
"ProductNDC": "0169-7830",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"NDCCode": "0169-7850-01",
"PackageDescription": "1 KIT in 1 KIT (0169-7850-01) * 4 mL in 1 VIAL, GLASS (0169-7851-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) ",
"NDC11Code": "00169-7850-01",
"ProductNDC": "0169-7850",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
"NonProprietaryName": "Antihemophilic Factor Recombinant",
"DosageFormName": "KIT",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .",
"Description": "Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight."
},
{
"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": "20261231",
"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": "20261231",
"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": "20261231",
"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."
}
]
}
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<NDC>
<NDCCode>41520-055-43</NDCCode>
<PackageDescription>454 g in 1 POUCH (41520-055-43)</PackageDescription>
<NDC11Code>41520-0055-43</NDC11Code>
<ProductNDC>41520-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Epsom Salt</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate</NonProprietaryName>
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<RouteName>ORAL; TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>FOODHOLD U.S.A., LLC</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-055-07</NDCCode>
<PackageDescription>1814 g in 1 POUCH (41520-055-07)</PackageDescription>
<NDC11Code>41520-0055-07</NDC11Code>
<ProductNDC>41520-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
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<LabelerName>FOODHOLD U.S.A., LLC</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for relief of occasional constipation (irregularity). this product generally produces bowel movement in 1/2 to 6 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37808-055-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (37808-055-43) </PackageDescription>
<NDC11Code>37808-0055-43</NDC11Code>
<ProductNDC>37808-055</ProductNDC>
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<ProprietaryName>Isopropyl</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent the risk of infection in: 1 minor cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-435-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-435-43) </PackageDescription>
<NDC11Code>41520-0435-43</NDC11Code>
<ProductNDC>41520-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anticavity</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
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<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Foodhold U.S.As., LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-804-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-804-43) </PackageDescription>
<NDC11Code>41520-0804-43</NDC11Code>
<ProductNDC>41520-804</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol</ProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FOODHOLD U.S.A., LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>.91</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150308</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-810-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-810-43) </PackageDescription>
<NDC11Code>41520-0810-43</NDC11Code>
<ProductNDC>41520-810</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>70%</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Foodhold U.S.A. LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-822-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-822-43) </PackageDescription>
<NDC11Code>41520-0822-43</NDC11Code>
<ProductNDC>41520-822</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Witch Hazel</ProprietaryName>
<NonProprietaryName>Witch Hazel</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>ADUSA Distribution, LLC</LabelerName>
<SubstanceName>WITCH HAZEL</SubstanceName>
<StrengthNumber>860</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of minor skin irritations due to: 1 insect bites, 2 minor cuts, 3 minor scrapes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-845-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-845-43) </PackageDescription>
<NDC11Code>41520-0845-43</NDC11Code>
<ProductNDC>41520-845</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Isopropyl Alcohol</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150407</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part344</ApplicationNumber>
<LabelerName>Foodhold U.S.A., LLC</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>613</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-877-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-877-43) </PackageDescription>
<NDC11Code>41520-0877-43</NDC11Code>
<ProductNDC>41520-877</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Oil</ProprietaryName>
<NonProprietaryName>Mineral Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20180709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Foodhold U.S.A.</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>999</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-942-43</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (41520-942-43) </PackageDescription>
<NDC11Code>41520-0942-43</NDC11Code>
<ProductNDC>41520-942</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>FOODHOLD U.S.A., LLC</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-345-43</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (23155-345-43) / 100 mL in 1 VIAL (23155-345-33) </PackageDescription>
<NDC11Code>23155-0345-43</NDC11Code>
<ProductNDC>23155-345</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20211012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.</IndicationAndUsage>
<Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>43598-055-04</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (43598-055-04) </PackageDescription>
<NDC11Code>43598-0055-04</NDC11Code>
<ProductNDC>43598-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nilotinib</ProprietaryName>
<NonProprietaryName>Nilotinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218350</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Inc</LabelerName>
<SubstanceName>NILOTINIB HYDROCHLORIDE MONOHYDRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nilotinib is a kinase inhibitor indicated for the treatment of: 1 Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. (1.2), 3 Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. (1.3) .</IndicationAndUsage>
<Description>Nilotinib capsules contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors. Nilotinib drug substance, in the form of hydrochloride monohydrate, is a white or slightly yellowish or slightly greenish yellow powder with the molecular formula and weight, respectively, of C28H25ClF3N7O2 and 584 g/mol (corresponding molecular formula and weight of nilotinib base, anhydrous are C28H22F3N7O and 529 g/mol, respectively). Freely soluble in dimethyl sulphoxide. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa value of nilotinib hydrochloride monohydrate is found to be 5.64. The chemical name of nilotinib hydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below. Nilotinib capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55.14 mg, 165.43 mg, and 220.57 mg nilotinib hydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer 188. The 50 mg and 150 mg capsules contain gelatin, iron oxide (red), iron oxide (yellow), sodium lauryl sulphate and titanium dioxide. The 200 mg capsules contain gelatin, iron oxide (yellow), sodium lauryl sulphate and titanium dioxide. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>50881-055-08</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-055-08) </PackageDescription>
<NDC11Code>50881-0055-08</NDC11Code>
<ProductNDC>50881-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jakafi Xr</ProprietaryName>
<NonProprietaryName>Ruxolitinib</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217180</ApplicationNumber>
<LabelerName>Incyte Corporation</LabelerName>
<SubstanceName>RUXOLITINIB</SubstanceName>
<StrengthNumber>55</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: 1 intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. (1.1), 2 polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. (1.2), 3 steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. (1.3), 4 chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. (1.4).</IndicationAndUsage>
<Description>Ruxolitinib phosphate is a kinase inhibitor with the chemical name (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36. Ruxolitinib phosphate has the following structural formula. Ruxolitinib phosphate is a white to off-white to light pink powder and is soluble in aqueous buffers across a pH range of 1 to 8. JAKAFI (ruxolitinib) tablets are for oral administration. Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg of ruxolitinib free base, equivalent to 6.6 mg, 13.2 mg, 19.8 mg, 26.4 mg, or 33 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. JAKAFI XR (ruxolitinib) extended-release tablets are for oral administration. Each tablet contains 11 mg, 22 mg, 33 mg, 44 mg, or 55 mg of ruxolitinib free base equivalent to 14.5 mg, 29 mg, 43.6 mg, 58.1 mg, or 72.6 mg of ruxolitinib phosphate, respectively, and the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: colorants (black iron oxide, red iron oxide, and yellow iron oxide), copovidone, hypromellose, polydextrose, polyethylene glycol, titanium dioxide, and triglycerides.</Description>
</NDC>
<NDC>
<NDCCode>63323-269-94</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (63323-269-94) / 20 mL in 1 VIAL (63323-269-43) </PackageDescription>
<NDC11Code>63323-0269-94</NDC11Code>
<ProductNDC>63323-269</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diprivan</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019627</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age, 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age, 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients, 4 Sedation for Adult Patients in Combination with Regional Anesthesia, 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.</IndicationAndUsage>
<Description>DIPRIVAN® (propofol) injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of DIPRIVAN® (Propofol) injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. DIPRIVAN is isotonic and has a pH of 7 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>82868-055-21</NDCCode>
<PackageDescription>21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-055-21) </PackageDescription>
<NDC11Code>82868-0055-21</NDC11Code>
<ProductNDC>82868-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078518</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for. Adult Patients (1.1): 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1–infected patientsReduction of transmission, 3 Herpes Zoster.</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride, USP (hydrous), which are equivalent to 500 mg or 1 gram of valacyclovir, on the anhydrous basis, respectively, and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. The white, film-coated tablets are printed with edible black ink which contains black iron oxide, propylene glycol and shellac glaze. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride, USP (hydrous) is a white to off-white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 7.47 and 9.43. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>83634-603-51</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (83634-603-51) / 100 mL in 1 VIAL (83634-603-43) </PackageDescription>
<NDC11Code>83634-0603-51</NDC11Code>
<ProductNDC>83634-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>Avenacy, LLC</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white homogeneous emulsion for intravenous administration. The structural formula is:. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol USP, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 6.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>41520-976-03</NDCCode>
<PackageDescription>1 g in 1 CONTAINER (41520-976-03)</PackageDescription>
<NDC11Code>41520-0976-03</NDC11Code>
<ProductNDC>41520-976</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Care One Medicated Lip Balm In A Pot</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130312</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>43.75</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent and temporarily protect dry and chapped lips.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0209-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0069-0209-10) / 20 mL in 1 VIAL (0069-0209-01) </PackageDescription>
<NDC11Code>00069-0209-10</NDC11Code>
<ProductNDC>0069-0209</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205576</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerin (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>0069-0234-20</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (0069-0234-20) / 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>00069-0234-20</NDC11Code>
<ProductNDC>0069-0234</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205576</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerin (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>0069-0248-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0069-0248-10) / 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>00069-0248-10</NDC11Code>
<ProductNDC>0069-0248</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205576</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.27. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of Propofol Injectable Emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerin (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>0093-4147-56</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00093-4147-56</NDC11Code>
<ProductNDC>0093-4147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levalbuterol</ProprietaryName>
<NonProprietaryName>Levalbuterol</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20141216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200875</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20141216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>Levalbuterol Inhalation Solution USP (Concentrate) is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol hydrochloride, USP is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol hydrochloride, USP is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows. The molecular weight of levalbuterol hydrochloride, USP is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 188°C and is soluble in water and slightly soluble in ethanol. Levalbuterol hydrochloride, USP is the USAN modified name for (R)-albuterol hydrochloride in the United States. Levalbuterol Inhalation Solution USP (Concentrate) is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP), 4 mg sodium chloride to adjust tonicity, and 0.055 mg edetate sodium dihydrate, 1 mg of trisodium citrate dihydrate, and sulfuric acid to adjust pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>0169-7810-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7810-01) * 4 mL in 1 VIAL, GLASS (0169-7811-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7810-01</NDC11Code>
<ProductNDC>0169-7810</ProductNDC>
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<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0169-7815-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7815-01) * 4 mL in 1 VIAL, GLASS (0169-7855-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7815-01</NDC11Code>
<ProductNDC>0169-7815</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0169-7820-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7820-01) * 4 mL in 1 VIAL, GLASS (0169-7821-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7820-01</NDC11Code>
<ProductNDC>0169-7820</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0169-7825-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7825-01) * 4 mL in 1 VIAL, GLASS (0169-7829-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7825-01</NDC11Code>
<ProductNDC>0169-7825</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0169-7830-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7830-01) * 4 mL in 1 VIAL, GLASS (0169-7831-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7830-01</NDC11Code>
<ProductNDC>0169-7830</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0169-7850-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-7850-01) * 4 mL in 1 VIAL, GLASS (0169-7851-11) * 4 mL in 1 SYRINGE, GLASS (0169-7008-98) </PackageDescription>
<NDC11Code>00169-7850-01</NDC11Code>
<ProductNDC>0169-7850</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor Recombinant</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Novoeight, Antihemophilic Factor (Recombinant), is a human antihemophilic factor (human blood coagulation. factor VIII (FVIII)) indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes , 2 Perioperative management , 3 Routine prophylaxis to reduce the frequency of bleeding episodes .</IndicationAndUsage>
<Description>Novoeight is formulated as a sterile, non-pyrogenic, lyophilized powder for intravenous injection after reconstitution with the diluent (0.9% sodium chloride). Novoeight is available in single-dose vials that contain nominally 250, 500, 1000, 1500, 2000 or 3000 international units (IU) per vial. When reconstituted with the appropriate volume of diluent, the product contains the following components per mL: 18 mg sodium chloride, 1.5 mg L-histidine, 3 mg sucrose, 0.1 mg polysorbate 80, 0.055 mg L-methionine and 0.25 mg calcium chloride dihydrate. The product contains no preservative. Each vial of Novoeight is labeled with the actual rFVIII activity expressed in IU determined by the one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for FVIII Concentrates. One IU, as defined by the WHO standard for human FVIII, is approximately equal to the level of FVIII activity in 1 mL of fresh pooled human plasma. The specific activity of Novoeight is approximately 8340 IU per milligram of protein. The active ingredient in Novoeight is a recombinant (r) analogue of human coagulation factor VIII (FVIII) with a molecular mass of 166 kDa, calculated excluding post-translational modifications. The rFVIII molecule in Novoeight is a glycoprotein containing a heavy chain and a light chain, with 21 of the 908 amino acids of the B-domain of endogenous FVIII connected to the C-terminus of the heavy chain. Once activated, the resulting rFVIIIa has a comparable structure to the endogenous FVIIIa. Novoeight is synthesized by a genetically engineered Chinese hamster ovary (CHO) cell line which secretes rFVIII into the cell culture medium. The rFVIII protein is purified using a series of chromatography steps, one of which is the use of an immunoaffinity column in which a monoclonal antibody, produced in CHO cells and directed against FVIII, is employed to selectively isolate the rFVIII from the medium. The production process includes two dedicated viral clearance steps - a detergent treatment step for inactivation and a 20-nm filtration step for removal of viruses. No additives of human or animal origin are used in the cell culture, purification and formulation of Novoeight.</Description>
</NDC>
<NDC>
<NDCCode>0378-0630-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0378-0630-01) </PackageDescription>
<NDC11Code>00378-0630-01</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>
<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>20261231</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>0378-0630-88</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>
<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>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>20261231</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>0378-0630-91</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>
<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>20261231</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>
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