{
"NDC": [
{
"NDCCode": "68462-166-07",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (68462-166-07) / 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "68462-0166-07",
"ProductNDC": "68462-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207985",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-166-15",
"PackageDescription": "28 CARTON in 1 CARTON (68462-166-15) / 14 BLISTER PACK in 1 CARTON (68462-166-41) / 14 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "68462-0166-15",
"ProductNDC": "68462-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207985",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "68462-166-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (68462-166-30) ",
"NDC11Code": "68462-0166-30",
"ProductNDC": "68462-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fingolimod",
"NonProprietaryName": "Fingolimod",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207985",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "FINGOLIMOD HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N",
"IndicationAndUsage": "Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.",
"Description": "Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac."
},
{
"NDCCode": "58420-002-07",
"PackageDescription": "166 L in 1 CYLINDER (58420-002-07)",
"NDC11Code": "58420-0002-07",
"ProductNDC": "58420-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Airgas Intermountain Inc",
"SubstanceName": "NITROGEN",
"StrengthNumber": "992",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "66267-166-07",
"PackageDescription": "7 TABLET in 1 BOTTLE (66267-166-07) ",
"NDC11Code": "66267-0166-07",
"ProductNDC": "66267-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phentermine Hydrochloride",
"NonProprietaryName": "Phentermine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130812",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040526",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "PHENTERMINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161012",
"SamplePackage": "N",
"IndicationAndUsage": "Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [ see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, FD&C Blue #1, magnesium stearate, and povidone."
},
{
"NDCCode": "71919-166-07",
"PackageDescription": "15 mL in 1 VIAL, GLASS (71919-166-07) ",
"NDC11Code": "71919-0166-07",
"ProductNDC": "71919-166",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carduus Marianus",
"NonProprietaryName": "Milk Thistle",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100226",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MILK THISTLE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100226",
"SamplePackage": "N"
},
{
"NDCCode": "68462-260-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-01) ",
"NDC11Code": "68462-0260-01",
"ProductNDC": "68462-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078906",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg."
},
{
"NDCCode": "68462-260-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-05) ",
"NDC11Code": "68462-0260-05",
"ProductNDC": "68462-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078906",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg."
},
{
"NDCCode": "68462-260-10",
"PackageDescription": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-10) ",
"NDC11Code": "68462-0260-10",
"ProductNDC": "68462-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078906",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg."
},
{
"NDCCode": "68462-260-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-30) ",
"NDC11Code": "68462-0260-30",
"ProductNDC": "68462-260",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078906",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "240",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090917",
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"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
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"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg."
},
{
"NDCCode": "68462-293-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-293-90) ",
"NDC11Code": "68462-0293-90",
"ProductNDC": "68462-293",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090700",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110805",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.",
"Description": "Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg."
},
{
"NDCCode": "0093-1106-16",
"PackageDescription": "1 SYRINGE in 1 CARTON (0093-1106-16) / 2.24 mL in 1 SYRINGE",
"NDC11Code": "00093-1106-16",
"ProductNDC": "0093-1106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teriparatide",
"NonProprietaryName": "Teriparatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208569",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "TERIPARATIDE ACETATE",
"StrengthNumber": "250",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "Teriparatide Injection is indicated: : 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide Injection reduces the risk of vertebral and nonvertebral fractures. , 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. , 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.",
"Description": "Teriparatide Injection, USP is a chemically synthesized human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide, USP is C181H291N55O51S2 and molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide, USP is manufactured by chemical synthesis. Teriparatide Injection, USP is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each delivery device (pen) is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg of teriparatide, USP (corrected for acetate, and water content), 0.41 mg of glacial acetic acid, 0.166 mg of sodium acetate (trihydrate), 45.4 mg of mannitol, 3 mg of metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the pH to 3.8 to 4.5. Each prefilled delivery device (pen) delivers 20 mcg of teriparatide, USP per dose for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times."
},
{
"NDCCode": "0169-8055-01",
"PackageDescription": "1 KIT in 1 KIT (0169-8055-01) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8051-11) ",
"NDC11Code": "00169-8055-01",
"ProductNDC": "0169-8055",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Esperoct",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Glycopegylated-exei",
"DosageFormName": "KIT",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125671",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N",
"IndicationAndUsage": "ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa."
},
{
"NDCCode": "0169-8100-01",
"PackageDescription": "1 KIT in 1 KIT (0169-8100-01) * 4 mL in 1 VIAL, GLASS (0169-8101-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8101-11) ",
"NDC11Code": "00169-8100-01",
"ProductNDC": "0169-8100",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Esperoct",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Glycopegylated-exei",
"DosageFormName": "KIT",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125671",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N",
"IndicationAndUsage": "ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa."
},
{
"NDCCode": "0169-8100-93",
"PackageDescription": "1 KIT in 1 KIT (0169-8100-93) * 4 mL in 1 VIAL, GLASS (0169-8101-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8101-11) ",
"NDC11Code": "00169-8100-93",
"ProductNDC": "0169-8100",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Esperoct",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Glycopegylated-exei",
"DosageFormName": "KIT",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125671",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N",
"IndicationAndUsage": "ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa."
},
{
"NDCCode": "0169-8150-01",
"PackageDescription": "1 KIT in 1 KIT (0169-8150-01) * 4 mL in 1 VIAL, GLASS (0169-8151-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) ",
"NDC11Code": "00169-8150-01",
"ProductNDC": "0169-8150",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Esperoct",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Glycopegylated-exei",
"DosageFormName": "KIT",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125671",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N",
"IndicationAndUsage": "ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa."
},
{
"NDCCode": "0169-8200-01",
"PackageDescription": "1 KIT in 1 KIT (0169-8200-01) * 4 mL in 1 VIAL, GLASS (0169-8201-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) ",
"NDC11Code": "00169-8200-01",
"ProductNDC": "0169-8200",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Esperoct",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Glycopegylated-exei",
"DosageFormName": "KIT",
"StartMarketingDate": "20190219",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125671",
"LabelerName": "Novo Nordisk",
"Status": "Active",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N",
"IndicationAndUsage": "ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.",
"Description": "ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa."
},
{
"NDCCode": "0169-8300-01",
"PackageDescription": "1 KIT in 1 KIT (0169-8300-01) * 4 mL in 1 VIAL, GLASS (0169-8301-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8301-11) ",
"NDC11Code": "00169-8300-01",
"ProductNDC": "0169-8300",
"ProductTypeName": "PLASMA DERIVATIVE",
"ProprietaryName": "Esperoct",
"NonProprietaryName": "Antihemophilic Factor (recombinant), Glycopegylated-exei",
"DosageFormName": "KIT",
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<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac.</Description>
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<NDC>
<NDCCode>68462-166-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (68462-166-30) </PackageDescription>
<NDC11Code>68462-0166-30</NDC11Code>
<ProductNDC>68462-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fingolimod</ProprietaryName>
<NonProprietaryName>Fingolimod</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207985</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>FINGOLIMOD HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.</IndicationAndUsage>
<Description>Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod hydrochloride is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below. Fingolimod hydrochloride, USP is a white to off-white powder that is freely soluble in alcohol, soluble in methanol, water and propylene glycol. It has a molecular weight of 343.93 g/mol. Fingolimod Capsules are provided as 0.5 mg hard gelatin capsules for oral use. Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, USP equivalent to 0.5 mg fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: magnesium stearate and pregelatinized starch. The capsule shell contains gelatin, iron oxide yellow and titanium dioxide. The imprinting ink contains iron oxide black, potassium hydroxide and shellac.</Description>
</NDC>
<NDC>
<NDCCode>58420-002-07</NDCCode>
<PackageDescription>166 L in 1 CYLINDER (58420-002-07)</PackageDescription>
<NDC11Code>58420-0002-07</NDC11Code>
<ProductNDC>58420-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Airgas Intermountain Inc</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>66267-166-07</NDCCode>
<PackageDescription>7 TABLET in 1 BOTTLE (66267-166-07) </PackageDescription>
<NDC11Code>66267-0166-07</NDC11Code>
<ProductNDC>66267-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phentermine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phentermine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130812</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040526</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PHENTERMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [ see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows. Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, FD&C Blue #1, magnesium stearate, and povidone.</Description>
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<NDC>
<NDCCode>71919-166-07</NDCCode>
<PackageDescription>15 mL in 1 VIAL, GLASS (71919-166-07) </PackageDescription>
<NDC11Code>71919-0166-07</NDC11Code>
<ProductNDC>71919-166</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carduus Marianus</ProprietaryName>
<NonProprietaryName>Milk Thistle</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100226</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>MILK THISTLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68462-260-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-01) </PackageDescription>
<NDC11Code>68462-0260-01</NDC11Code>
<ProductNDC>68462-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078906</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg.</Description>
</NDC>
<NDC>
<NDCCode>68462-260-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-05) </PackageDescription>
<NDC11Code>68462-0260-05</NDC11Code>
<ProductNDC>68462-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078906</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg.</Description>
</NDC>
<NDC>
<NDCCode>68462-260-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-10) </PackageDescription>
<NDC11Code>68462-0260-10</NDC11Code>
<ProductNDC>68462-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078906</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg.</Description>
</NDC>
<NDC>
<NDCCode>68462-260-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-260-30) </PackageDescription>
<NDC11Code>68462-0260-30</NDC11Code>
<ProductNDC>68462-260</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078906</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>240</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090917</StartMarketingDatePackage>
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<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110805</StartMarketingDatePackage>
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<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg.</Description>
</NDC>
<NDC>
<NDCCode>68462-293-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-293-90) </PackageDescription>
<NDC11Code>68462-0293-90</NDC11Code>
<ProductNDC>68462-293</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090700</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.</IndicationAndUsage>
<Description>Verapamil Hydrochloride Extended-Release Tablets, USP are calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). Verapamil Hydrochloride Extended-Release Tablets, USP are available for oral administration as brown colored, oval, biconvex, film-coated tablets containing 120 mg of verapamil hydrochloride, USP (equivalent to 111.08 mg verapamil free base), as brown colored, oval, biconvex, film-coated tablets containing 180 mg of verapamil hydrochloride, USP (equivalent to 166.62 mg verapamil free base), and as brown colored, oval, biconvex, film-coated tablets containing 240 mg of verapamil hydrochloride, USP (equivalent to 222.16 mg verapamil free base). The tablets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the tablet is divided in half. The structural formula of verapamil HCl, USP is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil HCl, USP is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in ether. Verapamil HCl, USP is not chemically related to other cardio active drugs. In addition to verapamil HCl, USP, the Verapamil Hydrochloride Extended-Release Tablets, USP contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium alginate, and titanium dioxide. The following are the color additives per tablet strength. FDA approved dissolution test specifications differ from USP for Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, 180 mg and 240 mg.</Description>
</NDC>
<NDC>
<NDCCode>0093-1106-16</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0093-1106-16) / 2.24 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00093-1106-16</NDC11Code>
<ProductNDC>0093-1106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teriparatide</ProprietaryName>
<NonProprietaryName>Teriparatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208569</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>TERIPARATIDE ACETATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teriparatide Injection is indicated: : 1 For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide Injection reduces the risk of vertebral and nonvertebral fractures. , 2 To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy. , 3 For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.</IndicationAndUsage>
<Description>Teriparatide Injection, USP is a chemically synthesized human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone. The molecular formula of teriparatide, USP is C181H291N55O51S2 and molecular weight is 4117.8 daltons. Its amino acid sequence is shown below. Teriparatide, USP is manufactured by chemical synthesis. Teriparatide Injection, USP is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a single-patient-use delivery device (pen) for subcutaneous injection. Each delivery device (pen) is filled with volume to allow delivery of 2.24 mL. Each mL contains 250 mcg of teriparatide, USP (corrected for acetate, and water content), 0.41 mg of glacial acetic acid, 0.166 mg of sodium acetate (trihydrate), 45.4 mg of mannitol, 3 mg of metacresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the pH to 3.8 to 4.5. Each prefilled delivery device (pen) delivers 20 mcg of teriparatide, USP per dose for up to 28 days. Each device contains additional volume to allow troubleshooting of the device 2 times.</Description>
</NDC>
<NDC>
<NDCCode>0169-8055-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-8055-01) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8051-11) </PackageDescription>
<NDC11Code>00169-8055-01</NDC11Code>
<ProductNDC>0169-8055</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Esperoct</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Glycopegylated-exei</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125671</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
</NDC>
<NDC>
<NDCCode>0169-8100-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-8100-01) * 4 mL in 1 VIAL, GLASS (0169-8101-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8101-11) </PackageDescription>
<NDC11Code>00169-8100-01</NDC11Code>
<ProductNDC>0169-8100</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Esperoct</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Glycopegylated-exei</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125671</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
</NDC>
<NDC>
<NDCCode>0169-8100-93</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-8100-93) * 4 mL in 1 VIAL, GLASS (0169-8101-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8101-11) </PackageDescription>
<NDC11Code>00169-8100-93</NDC11Code>
<ProductNDC>0169-8100</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Esperoct</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Glycopegylated-exei</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125671</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
</NDC>
<NDC>
<NDCCode>0169-8150-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-8150-01) * 4 mL in 1 VIAL, GLASS (0169-8151-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) </PackageDescription>
<NDC11Code>00169-8150-01</NDC11Code>
<ProductNDC>0169-8150</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Esperoct</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Glycopegylated-exei</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125671</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
</NDC>
<NDC>
<NDCCode>0169-8200-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (0169-8200-01) * 4 mL in 1 VIAL, GLASS (0169-8201-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) </PackageDescription>
<NDC11Code>00169-8200-01</NDC11Code>
<ProductNDC>0169-8200</ProductNDC>
<ProductTypeName>PLASMA DERIVATIVE</ProductTypeName>
<ProprietaryName>Esperoct</ProprietaryName>
<NonProprietaryName>Antihemophilic Factor (recombinant), Glycopegylated-exei</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20190219</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125671</ApplicationNumber>
<LabelerName>Novo Nordisk</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
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<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
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<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
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<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
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<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
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<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
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<IndicationAndUsage>ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for: 1 On-demand treatment and control of bleeding episodes, 2 Perioperative management of bleeding, 3 Routine prophylaxis to reduce the frequency of bleeding episodes.</IndicationAndUsage>
<Description>ESPEROCT is a sterile, preservative-free, non-pyrogenic lyophilized powder for intravenous injection after reconstitution with the provided saline diluent. The active ingredient in ESPEROCT is a recombinant analogue of human coagulation Factor VIII (FVIII) conjugated with a 40-kDa polyethylene glycol (PEG) molecule. ESPEROCT is formulated with the following excipients: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride. FVIII activity in ESPEROCT is determined using the chromogenic assay described in the European Pharmacopoeia. The activity assignment employs a FVIII reference material that is traceable to the current World Health Organization (WHO) international standard for FVIII concentrate, and evaluated by appropriate methodologies to ensure the accuracy of the results. ESPEROCT is available in single-dose vials that contain nominally 500, 1000, 1500, 2000, 3000, 4000, or 5000 IU of FVIII. Each vial of ESPEROCT is labeled with the actual FVIII activity. After reconstitution with the supplied diluent (0.9% saline), each mL of the solution contains approximately 125, 250, 375, 500, 750, 1000, or 1250 IU of FVIII, respectively. The FVIII protein in ESPEROCT is produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology, and contains a truncated B domain, which is O-glycosylated. The polypeptide part of the molecule has a molecular mass of 166 kDa (calculated excluding post-translational modifications) and represents a heterodimer of a heavy chain and a light chain, which are held together by non-covalent interactions. The recombinant FVIII protein is purified using a series of chromatographic steps, one of which is affinity chromatography, with the use of a monoclonal antibody to selectively isolate the rFVIII from the cell culture medium. The 40-kDa PEG molecule is conjugated to the O-glycan moiety of the B domain using an enzymatic reaction to produce a glycopegylated FVIII (FVIII-PEG). The purification process includes two viral clearance steps, namely detergent treatment for inactivation of enveloped viruses, and 20-nm filtration for removal of enveloped and non-enveloped viruses. No additives of human or animal origin are used during the manufacturing process and formulation of ESPEROCT. In the blood circulation, when FVIII-PEG is activated by thrombin, the B-domain portion with the attached PEG moiety is cleaved off, and the resulting activated FVIII (FVIIIa) is similar in structure and function to native FVIIIa.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nefazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Nefazodone Hydrochloride</NonProprietaryName>
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<IndicationAndUsage>Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Nefazodone hydrochloride tablets USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.</Description>
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<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Nefazodone hydrochloride tablets USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI). Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is. C25H32CIN5O2HCl M.W. 506.5. Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water. Nefazodone hydrochloride tablets USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.</Description>
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