{
"NDC": [
{
"NDCCode": "68001-554-00",
"PackageDescription": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-554-00) ",
"NDC11Code": "68001-0554-00",
"ProductNDC": "68001-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220810",
"SamplePackage": "N"
},
{
"NDCCode": "68001-554-03",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-554-03) ",
"NDC11Code": "68001-0554-03",
"ProductNDC": "68001-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078597",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-09-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220810",
"SamplePackage": "N"
},
{
"NDCCode": "55239-554-00",
"PackageDescription": "40 PATCH in 1 CANISTER (55239-554-00) / 4.5 mL in 1 PATCH",
"NDC11Code": "55239-0554-00",
"ProductNDC": "55239-554",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pharma-c-wipes Toallitas De Alcohol Isopropilico 70",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Kleen Test Products Corporation",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N"
},
{
"NDCCode": "65121-554-00",
"PackageDescription": "205 kg in 1 DRUM (65121-554-00) ",
"NDC11Code": "65121-0554-00",
"ProductNDC": "65121-554",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240805",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Pure Source, LLC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-09-20",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "05-AUG-24"
},
{
"NDCCode": "67457-554-00",
"PackageDescription": "1 BAG in 1 POUCH (67457-554-00) / 100 mL in 1 BAG",
"NDC11Code": "67457-0554-00",
"ProductNDC": "67457-554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Sulfate",
"NonProprietaryName": "Magnesium Sulfate Heptahydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201002",
"EndMarketingDate": "20250930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209911",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "MAGNESIUM SULFATE HEPTAHYDRATE",
"StrengthNumber": "4",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201002",
"EndMarketingDatePackage": "20250930",
"SamplePackage": "N",
"IndicationAndUsage": "Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.",
"Description": "Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic, clear, colorless solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% concentration. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from polypropylene. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."
},
{
"NDCCode": "68001-001-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-001-00) ",
"NDC11Code": "68001-0001-00",
"ProductNDC": "68001-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Monohydrate/macrocrystalline",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystalline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130320",
"EndMarketingDate": "20210531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020064",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130320",
"EndMarketingDatePackage": "20210531",
"SamplePackage": "N"
},
{
"NDCCode": "68001-002-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (68001-002-00) ",
"NDC11Code": "68001-0002-00",
"ProductNDC": "68001-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Macrocrystals",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016620",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130320",
"SamplePackage": "N"
},
{
"NDCCode": "68001-003-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (68001-003-00) ",
"NDC11Code": "68001-0003-00",
"ProductNDC": "68001-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Macrocrystals",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130320",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016620",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130320",
"SamplePackage": "N"
},
{
"NDCCode": "68001-004-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (68001-004-00) ",
"NDC11Code": "68001-0004-00",
"ProductNDC": "68001-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metaxalone",
"NonProprietaryName": "Metaxalone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140422",
"EndMarketingDate": "20230731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203399",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METAXALONE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140422",
"EndMarketingDatePackage": "20230731",
"SamplePackage": "N"
},
{
"NDCCode": "68001-006-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68001-006-00) ",
"NDC11Code": "68001-0006-00",
"ProductNDC": "68001-006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130724",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078926",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130724",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "68001-007-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68001-007-00) ",
"NDC11Code": "68001-0007-00",
"ProductNDC": "68001-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130724",
"EndMarketingDate": "20220228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078926",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130724",
"EndMarketingDatePackage": "20220228",
"SamplePackage": "N"
},
{
"NDCCode": "68001-105-00",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-105-00) ",
"NDC11Code": "68001-0105-00",
"ProductNDC": "68001-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131008",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078239",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131008",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N"
},
{
"NDCCode": "68001-106-00",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-00) ",
"NDC11Code": "68001-0106-00",
"ProductNDC": "68001-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131008",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078239",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131008",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N"
},
{
"NDCCode": "68001-119-00",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-119-00) ",
"NDC11Code": "68001-0119-00",
"ProductNDC": "68001-119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078889",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131125",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "68001-120-00",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-120-00) ",
"NDC11Code": "68001-0120-00",
"ProductNDC": "68001-120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078889",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2019-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131125",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).",
"Description": "Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "68001-121-00",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-121-00) ",
"NDC11Code": "68001-0121-00",
"ProductNDC": "68001-121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris ( 1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.( 1.3).",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "68001-122-00",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-122-00) ",
"NDC11Code": "68001-0122-00",
"ProductNDC": "68001-122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090617",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris ( 1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.( 1.3).",
"Description": "Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide."
},
{
"NDCCode": "68001-129-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-129-00) ",
"NDC11Code": "68001-0129-00",
"ProductNDC": "68001-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131223",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090223",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20131223",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "68001-130-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-130-00) ",
"NDC11Code": "68001-0130-00",
"ProductNDC": "68001-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078466",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150716",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "68001-131-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-131-00) ",
"NDC11Code": "68001-0131-00",
"ProductNDC": "68001-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078466",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150716",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "68001-132-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-132-00) ",
"NDC11Code": "68001-0132-00",
"ProductNDC": "68001-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078466",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "2.5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150716",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "68001-133-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-133-00) ",
"NDC11Code": "68001-0133-00",
"ProductNDC": "68001-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078466",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150716",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "68001-134-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-134-00) ",
"NDC11Code": "68001-0134-00",
"ProductNDC": "68001-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078466",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150716",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "68001-135-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-135-00) ",
"NDC11Code": "68001-0135-00",
"ProductNDC": "68001-135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"NonProprietaryName": "Amlodipine Besylate And Benazepril Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150716",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078466",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "5; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150716",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).",
"Description": "Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide."
},
{
"NDCCode": "68001-141-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-141-00) ",
"NDC11Code": "68001-0141-00",
"ProductNDC": "68001-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"EndMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078832",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140101",
"EndMarketingDatePackage": "20210930",
"SamplePackage": "N"
},
{
"NDCCode": "68001-142-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-142-00) ",
"NDC11Code": "68001-0142-00",
"ProductNDC": "68001-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"EndMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078832",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140101",
"EndMarketingDatePackage": "20210930",
"SamplePackage": "N"
},
{
"NDCCode": "68001-143-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (68001-143-00) ",
"NDC11Code": "68001-0143-00",
"ProductNDC": "68001-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140101",
"EndMarketingDate": "20210930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078832",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140101",
"EndMarketingDatePackage": "20210930",
"SamplePackage": "N"
},
{
"NDCCode": "68001-144-00",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-144-00)",
"NDC11Code": "68001-0144-00",
"ProductNDC": "68001-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131202",
"EndMarketingDate": "20151031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202128",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "68001-151-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68001-151-00) ",
"NDC11Code": "68001-0151-00",
"ProductNDC": "68001-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077614",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140422",
"SamplePackage": "N",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3."
},
{
"NDCCode": "68001-152-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68001-152-00) ",
"NDC11Code": "68001-0152-00",
"ProductNDC": "68001-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077614",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140422",
"SamplePackage": "N",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>68001-554-00</NDCCode>
<PackageDescription>100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-554-00) </PackageDescription>
<NDC11Code>68001-0554-00</NDC11Code>
<ProductNDC>68001-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-554-03</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-554-03) </PackageDescription>
<NDC11Code>68001-0554-03</NDC11Code>
<ProductNDC>68001-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078597</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55239-554-00</NDCCode>
<PackageDescription>40 PATCH in 1 CANISTER (55239-554-00) / 4.5 mL in 1 PATCH</PackageDescription>
<NDC11Code>55239-0554-00</NDC11Code>
<ProductNDC>55239-554</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharma-c-wipes Toallitas De Alcohol Isopropilico 70</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Kleen Test Products Corporation</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65121-554-00</NDCCode>
<PackageDescription>205 kg in 1 DRUM (65121-554-00) </PackageDescription>
<NDC11Code>65121-0554-00</NDC11Code>
<ProductNDC>65121-554</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240805</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Pure Source, LLC</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-09-20</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-AUG-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67457-554-00</NDCCode>
<PackageDescription>1 BAG in 1 POUCH (67457-554-00) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>67457-0554-00</NDC11Code>
<ProductNDC>67457-554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Magnesium Sulfate Heptahydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201002</StartMarketingDate>
<EndMarketingDate>20250930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209911</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>MAGNESIUM SULFATE HEPTAHYDRATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201002</StartMarketingDatePackage>
<EndMarketingDatePackage>20250930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.</IndicationAndUsage>
<Description>Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic, clear, colorless solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% concentration. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes. Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 7H2O, colorless crystals or white powder freely soluble in water. Water for Injection, USP is chemically designated H2O. The flexible plastic container is fabricated from polypropylene. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.</Description>
</NDC>
<NDC>
<NDCCode>68001-001-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-001-00) </PackageDescription>
<NDC11Code>68001-0001-00</NDC11Code>
<ProductNDC>68001-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Monohydrate/macrocrystalline</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystalline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<EndMarketingDate>20210531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020064</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC],Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<EndMarketingDatePackage>20210531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-002-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (68001-002-00) </PackageDescription>
<NDC11Code>68001-0002-00</NDC11Code>
<ProductNDC>68001-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016620</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-003-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (68001-003-00) </PackageDescription>
<NDC11Code>68001-0003-00</NDC11Code>
<ProductNDC>68001-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130320</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016620</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130320</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-004-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68001-004-00) </PackageDescription>
<NDC11Code>68001-0004-00</NDC11Code>
<ProductNDC>68001-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metaxalone</ProprietaryName>
<NonProprietaryName>Metaxalone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140422</StartMarketingDate>
<EndMarketingDate>20230731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203399</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>METAXALONE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140422</StartMarketingDatePackage>
<EndMarketingDatePackage>20230731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-006-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68001-006-00) </PackageDescription>
<NDC11Code>68001-0006-00</NDC11Code>
<ProductNDC>68001-006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130724</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078926</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130724</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-007-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68001-007-00) </PackageDescription>
<NDC11Code>68001-0007-00</NDC11Code>
<ProductNDC>68001-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130724</StartMarketingDate>
<EndMarketingDate>20220228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078926</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130724</StartMarketingDatePackage>
<EndMarketingDatePackage>20220228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-105-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-105-00) </PackageDescription>
<NDC11Code>68001-0105-00</NDC11Code>
<ProductNDC>68001-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131008</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078239</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131008</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-106-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-106-00) </PackageDescription>
<NDC11Code>68001-0106-00</NDC11Code>
<ProductNDC>68001-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131008</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078239</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131008</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-119-00</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-119-00) </PackageDescription>
<NDC11Code>68001-0119-00</NDC11Code>
<ProductNDC>68001-119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078889</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-120-00</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-120-00) </PackageDescription>
<NDC11Code>68001-0120-00</NDC11Code>
<ProductNDC>68001-120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078889</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) , 2 Angina Pectoris (1.2), 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.(1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 95 mg and 190 mg of metoprolol succinate equivalent to 100 mg and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-121-00</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-121-00) </PackageDescription>
<NDC11Code>68001-0121-00</NDC11Code>
<ProductNDC>68001-121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris ( 1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.( 1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-122-00</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-122-00) </PackageDescription>
<NDC11Code>68001-0122-00</NDC11Code>
<ProductNDC>68001-122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090617</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1-selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are indicated for the treatment of: : 1 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1) , 2 Angina Pectoris ( 1.2) , 3 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.( 1.3).</IndicationAndUsage>
<Description>Metoprolol succinate, is a beta 1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Metoprolol succinate extended-release tablets USP, have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75 mg and 47.5 mg of metoprolol succinate equivalent to 25 mg and 50 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:. Metoprolol succinate USP, is a white to off white powder with a molecular weight of 652.8. It is freely soluble in water and soluble in methanol. Inactive ingredients: acetyl tributyl citrate, colloidal silicon dioxide, croscarmellose sodium, ethyl cellulose, hydrogenated vegetable oil, hydroxypropyl cellulose, hypromellose, methylene chloride, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-129-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-129-00) </PackageDescription>
<NDC11Code>68001-0129-00</NDC11Code>
<ProductNDC>68001-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131223</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090223</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20131223</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-130-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-130-00) </PackageDescription>
<NDC11Code>68001-0130-00</NDC11Code>
<ProductNDC>68001-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078466</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-131-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-131-00) </PackageDescription>
<NDC11Code>68001-0131-00</NDC11Code>
<ProductNDC>68001-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Amlodipine Besylate And Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150716</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078466</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
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<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-132-00) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078466</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-133-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-133-00) </PackageDescription>
<NDC11Code>68001-0133-00</NDC11Code>
<ProductNDC>68001-133</ProductNDC>
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<ApplicationNumber>ANDA078466</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-134-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-134-00) </PackageDescription>
<NDC11Code>68001-0134-00</NDC11Code>
<ProductNDC>68001-134</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078466</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-135-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-135-00) </PackageDescription>
<NDC11Code>68001-0135-00</NDC11Code>
<ProductNDC>68001-135</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078466</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1).</IndicationAndUsage>
<Description>Amlodipine and benazepril hydrochloride capsules, USP are a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1 H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is. Its empirical formula is C 24H 28N 2O 5HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Amlodipine besylate is a white to almost white powder, slightly soluble in water and sparingly soluble in ethanol. Its chemical name is (R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate; its structural formula is. Its empirical formula is C 20H 25ClN 2O 5C 6H 6O 3S, and its molecular weight is 567.1. Amlodipine besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. Amlodipine and benazepril hydrochloride capsules USP are formulated in 6 different strengths for oral administration with a combination of amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. The inactive ingredients of the capsules are crospovidone, hydrophobic fumed silica, lactose anhydrous, magnesium stearate, microcrystalline cellulose, povidone, gelatin, titanium dioxide (not present in 10 mg/20 mg strength), black iron oxide, red iron oxide (present in 5 mg/10 mg, 5 mg/20 mg and 10 mg/ 20 mg strength), yellow iron oxide, (present in 5 mg/10 mg strength), D&C Yellow #10 (present in 5 mg/40 mg strength), FD&C Blue #1 (present in 10 mg/40 mg strength), FD&C Blue #2 (present in 10 mg/20 mg strength), FD&C Green #3 (present in 5 mg/40 mg strength),FD&C Red #40 (present in 10 mg/40 mg strength), FD&C Yellow #6 (present in 5 mg/ 40 mg strength), shellac, propylene glycol, potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68001-141-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-141-00) </PackageDescription>
<NDC11Code>68001-0141-00</NDC11Code>
<ProductNDC>68001-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<EndMarketingDate>20210930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078832</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-142-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-142-00) </PackageDescription>
<NDC11Code>68001-0142-00</NDC11Code>
<ProductNDC>68001-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<EndMarketingDate>20210930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078832</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-143-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (68001-143-00) </PackageDescription>
<NDC11Code>68001-0143-00</NDC11Code>
<ProductNDC>68001-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140101</StartMarketingDate>
<EndMarketingDate>20210930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078832</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68001-144-00</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-144-00)</PackageDescription>
<NDC11Code>68001-0144-00</NDC11Code>
<ProductNDC>68001-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<EndMarketingDate>20151031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202128</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>68001-151-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68001-151-00) </PackageDescription>
<NDC11Code>68001-0151-00</NDC11Code>
<ProductNDC>68001-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077614</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>68001-152-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68001-152-00) </PackageDescription>
<NDC11Code>68001-0152-00</NDC11Code>
<ProductNDC>68001-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077614</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol, USP is a white to almost white crystalline powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethylsulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5). Each carvedilol tablet, USP intended for oral administration contains 3.125 mg or 6.25 mg or 12.5 mg or 25 mg of carvedilol. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc and titanium dioxide. The product meets USP Dissolution Test 3.</Description>
</NDC>
</NDCList>