{
"NDC": [
{
"NDCCode": "70605-055-11",
"PackageDescription": "30 mL in 1 TUBE (70605-055-11) ",
"NDC11Code": "70605-0055-11",
"ProductNDC": "70605-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lumipearl Dark Mark Corrector",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358A",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171230",
"SamplePackage": "N"
},
{
"NDCCode": "70605-055-02",
"PackageDescription": "10 mL in 1 TUBE (70605-055-02) ",
"NDC11Code": "70605-0055-02",
"ProductNDC": "70605-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lumipearl Dark Mark Corrector",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358A",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "HYDROQUINONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171230",
"SamplePackage": "N"
},
{
"NDCCode": "70605-022-11",
"PackageDescription": "30 g in 1 TUBE (70605-022-11) ",
"NDC11Code": "70605-0022-11",
"ProductNDC": "70605-022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amla Glow Ultra Hydrating Day Moisturizer Broad Spectrum Spf 25 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 8; 5; 2.7; 3",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171231",
"SamplePackage": "N"
},
{
"NDCCode": "70605-026-11",
"PackageDescription": "30 mL in 1 TUBE (70605-026-11) ",
"NDC11Code": "70605-0026-11",
"ProductNDC": "70605-026",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jane Seymour Natural Advantage Am Spf 15 All Day Moisture With Ahas",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guthy-Renker,LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "2; 10; 5; 1.3; 4",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171230",
"SamplePackage": "N"
},
{
"NDCCode": "68084-055-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (68084-055-01) > 1 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-055-11)",
"NDC11Code": "68084-0055-01",
"ProductNDC": "68084-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "American Health Packaging",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "70377-055-11",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70377-055-11) ",
"NDC11Code": "70377-0055-11",
"ProductNDC": "70377-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213486",
"LabelerName": "Biocon Pharma Inc.,",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210319",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.17 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules are supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent as 22.25 mg, or 44.50 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol."
},
{
"NDCCode": "71209-055-11",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (71209-055-11) ",
"NDC11Code": "71209-0055-11",
"ProductNDC": "71209-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151208",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208701",
"LabelerName": "Cadila Pharmaceuticals Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180823",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.The inactive ingredients in celecoxib capsules include: lactose monohydrate, crospovidone, sodium lauryl sulphate, polyvinyl pyrrolidone, magnesium stearate and gelatin. The gelatin capsule shell of the 50 mg strength contains gelatin, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 100 mg strength contains FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 200 mg strength contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 400 mg strength contains FD&C blue 1, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The dyes of the imprinting ink for 50 mg, 100 mg, 200 mg and 400 mg strength contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, shellac and strong ammonia solution."
},
{
"NDCCode": "71220-055-11",
"PackageDescription": "1 CONTAINER in 1 CARTON (71220-055-11) > 30 g in 1 CONTAINER",
"NDC11Code": "71220-0055-11",
"ProductNDC": "71220-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Matte Full Cover Foundation C13",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Innisfree Corporation",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".9",
"StrengthUnit": "g/30g",
"Status": "Deprecated",
"LastUpdate": "2019-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170623",
"SamplePackage": "N"
},
{
"NDCCode": "72241-055-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (72241-055-11) ",
"NDC11Code": "72241-0055-11",
"ProductNDC": "72241-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210022",
"LabelerName": "Modavar Pharmaceuticals LLC",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240117",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin."
},
{
"NDCCode": "83252-055-00",
"PackageDescription": ".11 kg in 1 BOTTLE, PUMP (83252-055-00) ",
"NDC11Code": "83252-0055-00",
"ProductNDC": "83252-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ellegreen Sunscreen Broad Spectrum Spf50",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240415",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Veganic SKN Limited",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "25",
"StrengthUnit": "kg/100kg",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240415",
"SamplePackage": "N"
},
{
"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": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "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."
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{
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"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."
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{
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"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
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"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."
},
{
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"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
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"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."
},
{
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"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) ",
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"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Novoeight",
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"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."
},
{
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"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",
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"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125466",
"LabelerName": "Novo Nordisk",
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"LastUpdate": "2024-05-25",
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"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."
},
{
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"ProductNDC": "12579-055",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
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"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
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"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-10-05",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "16-NOV-11"
},
{
"NDCCode": "16714-528-10",
"PackageDescription": "10 VIAL in 1 CARTON (16714-528-10) / 20 mL in 1 VIAL (16714-528-01) ",
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"ProductNDC": "16714-528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220701",
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"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."
},
{
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"MarketingCategoryName": "ANDA",
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"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PROPOFOL",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
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"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"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."
},
{
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"ProductNDC": "16714-690",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"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."
},
{
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"PackageDescription": "20 VIAL in 1 CARTON (16714-977-20) / 50 mL in 1 VIAL (16714-977-01) ",
"NDC11Code": "16714-0977-20",
"ProductNDC": "16714-977",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206408",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "23155-055-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (23155-055-03) ",
"NDC11Code": "23155-0055-03",
"ProductNDC": "23155-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110315",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "23155-055-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (23155-055-05) ",
"NDC11Code": "23155-0055-05",
"ProductNDC": "23155-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20110315",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
"NDCCode": "23155-055-19",
"PackageDescription": "9 TABLET in 1 BLISTER PACK (23155-055-19) ",
"NDC11Code": "23155-0055-19",
"ProductNDC": "23155-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naratriptan",
"NonProprietaryName": "Naratriptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200502",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "NARATRIPTAN HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110315",
"SamplePackage": "N",
"IndicationAndUsage": "Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.",
"Description": "Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
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"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."
},
{
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"PackageDescription": "20 VIAL in 1 CARTON (23155-345-42) / 50 mL in 1 VIAL (23155-345-32) ",
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"ProductNDC": "23155-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
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"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."
},
{
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"ProductNDC": "23155-345",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
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"PackageNdcExcludeFlag": "N",
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"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."
}
]
}
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
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<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: : 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2 Mg x 3 H2O with molecular weight of 767.17 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is. Figure 1. The magnesium salt is a white to slightly colored powder. It contains 3 moles of water of solvation and is slightly soluble in methanol, insoluble in water and in n-Heptane. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium delayed-release capsules are supplied in delayed-release capsules. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (equivalent as 22.25 mg, or 44.50 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>71209-055-11</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (71209-055-11) </PackageDescription>
<NDC11Code>71209-0055-11</NDC11Code>
<ProductNDC>71209-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208701</ApplicationNumber>
<LabelerName>Cadila Pharmaceuticals Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure. Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.The inactive ingredients in celecoxib capsules include: lactose monohydrate, crospovidone, sodium lauryl sulphate, polyvinyl pyrrolidone, magnesium stearate and gelatin. The gelatin capsule shell of the 50 mg strength contains gelatin, iron oxide red, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 100 mg strength contains FD&C blue 1, FD&C red 40, gelatin, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 200 mg strength contains gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The gelatin capsule shell of the 400 mg strength contains FD&C blue 1, gelatin, iron oxide yellow, sodium lauryl sulfate and titanium dioxide.The dyes of the imprinting ink for 50 mg, 100 mg, 200 mg and 400 mg strength contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>71220-055-11</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (71220-055-11) > 30 g in 1 CONTAINER</PackageDescription>
<NDC11Code>71220-0055-11</NDC11Code>
<ProductNDC>71220-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Matte Full Cover Foundation C13</ProprietaryName>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Innisfree Corporation</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>g/30g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72241-055-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (72241-055-11) </PackageDescription>
<NDC11Code>72241-0055-11</NDC11Code>
<ProductNDC>72241-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210022</ApplicationNumber>
<LabelerName>Modavar Pharmaceuticals LLC</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated:As oral formulation for the: Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.As Olanzapine IntraMuscular for the: Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. (1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each film-coated tablet contains olanzapine, USP equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose (Avicel PH101) and microcrystalline cellulose (Avicel PH102). The color coating contains hypromellose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>83252-055-00</NDCCode>
<PackageDescription>.11 kg in 1 BOTTLE, PUMP (83252-055-00) </PackageDescription>
<NDC11Code>83252-0055-00</NDC11Code>
<ProductNDC>83252-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ellegreen Sunscreen Broad Spectrum Spf50</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240415</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Veganic SKN Limited</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</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>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>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>
<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>0169-7815-01</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>
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<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>
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<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>
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<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>
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<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Novoeight</ProprietaryName>
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<DosageFormName>KIT</DosageFormName>
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<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
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<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<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>
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<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>
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<ApplicationNumber>BLA125466</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<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>12579-055-00</NDCCode>
<PackageDescription>456000 TABLET in 1 DRUM (12579-055-00) </PackageDescription>
<NDC11Code>12579-0055-00</NDC11Code>
<ProductNDC>12579-055</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Glyburide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20111116</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>OPELLA HEALTHCARE INTERNATIONAL SAS</LabelerName>
<SubstanceName>GLYBURIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-10-05</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-NOV-11</StartMarketingDatePackage>
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<NDC>
<NDCCode>16714-528-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (16714-528-10) / 20 mL in 1 VIAL (16714-528-01) </PackageDescription>
<NDC11Code>16714-0528-10</NDC11Code>
<ProductNDC>16714-528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>NorthStar Rx 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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220701</StartMarketingDatePackage>
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<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>16714-528-20</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (16714-528-20) / 20 mL in 1 VIAL (16714-528-01) </PackageDescription>
<NDC11Code>16714-0528-20</NDC11Code>
<ProductNDC>16714-528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>NorthStar Rx 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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220701</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>16714-690-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (16714-690-10) / 100 mL in 1 VIAL (16714-690-01) </PackageDescription>
<NDC11Code>16714-0690-10</NDC11Code>
<ProductNDC>16714-690</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>NorthStar Rx 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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>16714-977-20</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (16714-977-20) / 50 mL in 1 VIAL (16714-977-01) </PackageDescription>
<NDC11Code>16714-0977-20</NDC11Code>
<ProductNDC>16714-977</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206408</ApplicationNumber>
<LabelerName>NorthStar Rx 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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>23155-055-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (23155-055-03) </PackageDescription>
<NDC11Code>23155-0055-03</NDC11Code>
<ProductNDC>23155-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
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<NDC>
<NDCCode>23155-055-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (23155-055-05) </PackageDescription>
<NDC11Code>23155-0055-05</NDC11Code>
<ProductNDC>23155-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>23155-055-19</NDCCode>
<PackageDescription>9 TABLET in 1 BLISTER PACK (23155-055-19) </PackageDescription>
<NDC11Code>23155-0055-19</NDC11Code>
<ProductNDC>23155-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naratriptan</ProprietaryName>
<NonProprietaryName>Naratriptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200502</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NARATRIPTAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks., 2 Naratriptan tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of naratriptan tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Naratriptan tablets, USP contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure. The empirical formula is C17 H25 N3 O2 SHCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each naratriptan tablets, USP for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride, equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 1 mg tablet additionally contains opadry yellow, which contains: hypromellose 2910, titanium dioxide, polyethylene glycol 400 and iron oxide yellow. 2.5 mg tablet additionally contains opadry white, which contains: hypromellose 2910, talc, polyethylene glycol 8000 and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>23155-345-41</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (23155-345-41) / 20 mL in 1 VIAL (23155-345-31) </PackageDescription>
<NDC11Code>23155-0345-41</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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>23155-345-42</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (23155-345-42) / 50 mL in 1 VIAL (23155-345-32) </PackageDescription>
<NDC11Code>23155-0345-42</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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>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>2026-09-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</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>
</NDCList>