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"PackageDescription": "17 g in 1 TUBE (84440-619-17) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scaraid Spf",
"NonProprietaryName": "Silicone Stick With Spf",
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"LabelerName": "Biodermis, LLC",
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"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLYDE-ON THERAPY FOR YOUR SCARS."
},
{
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"PackageDescription": "17 g in 1 TUBE (84440-608-17) ",
"NDC11Code": "84440-0608-17",
"ProductNDC": "84440-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pro-sil Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
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"StrengthUnit": "mg/g; mg/g; mg/g",
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"SamplePackage": "N",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS."
},
{
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"PackageDescription": "17 g in 1 TUBE (84440-626-17) ",
"NDC11Code": "84440-0626-17",
"ProductNDC": "84440-626",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scaraid Us Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS."
},
{
"NDCCode": "84440-619-01",
"PackageDescription": "1 g in 1 TUBE (84440-619-01) ",
"NDC11Code": "84440-0619-01",
"ProductNDC": "84440-619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scaraid Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "Y",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLYDE-ON THERAPY FOR YOUR SCARS."
},
{
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"PackageDescription": "4.25 g in 1 TUBE (84440-619-42) ",
"NDC11Code": "84440-0619-42",
"ProductNDC": "84440-619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scaraid Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLYDE-ON THERAPY FOR YOUR SCARS."
},
{
"NDCCode": "43269-619-17",
"PackageDescription": "517 mL in 1 BOTTLE (43269-619-17)",
"NDC11Code": "43269-0619-17",
"ProductNDC": "43269-619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mango Spice Antibacterial Foaming Handwash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100623",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".2",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
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"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE (65841-619-17) ",
"NDC11Code": "65841-0619-17",
"ProductNDC": "65841-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077614",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20070905",
"SamplePackage": "N"
},
{
"NDCCode": "61919-619-15",
"PackageDescription": "15 g in 1 TUBE (61919-619-15) ",
"NDC11Code": "61919-0619-15",
"ProductNDC": "61919-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA087385",
"LabelerName": "DIRECTRX",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210204",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. [chemstructure]. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "65862-619-19",
"PackageDescription": "10000 TABLET, FILM COATED in 1 BOTTLE (65862-619-19) ",
"NDC11Code": "65862-0619-19",
"ProductNDC": "65862-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202725",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130429",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "65862-619-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (65862-619-30) ",
"NDC11Code": "65862-0619-30",
"ProductNDC": "65862-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202725",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130429",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "65862-619-61",
"PackageDescription": "6000 TABLET, FILM COATED in 1 BAG (65862-619-61) ",
"NDC11Code": "65862-0619-61",
"ProductNDC": "65862-619",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-05-17",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-APR-13"
},
{
"NDCCode": "65862-619-78",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65862-619-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-619-10) ",
"NDC11Code": "65862-0619-78",
"ProductNDC": "65862-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202725",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130429",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "65862-619-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (65862-619-90) ",
"NDC11Code": "65862-0619-90",
"ProductNDC": "65862-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202725",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130429",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "65862-619-99",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-619-99) ",
"NDC11Code": "65862-0619-99",
"ProductNDC": "65862-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinapril",
"NonProprietaryName": "Quinapril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130429",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202725",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "QUINAPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130429",
"SamplePackage": "N",
"IndicationAndUsage": "Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.",
"Description": "Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide."
},
{
"NDCCode": "68382-619-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) ",
"NDC11Code": "68382-0619-10",
"ProductNDC": "68382-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam",
"NonProprietaryName": "Colesevelam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207765",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191011",
"SamplePackage": "N",
"IndicationAndUsage": "Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).",
"Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets)."
},
{
"NDCCode": "68382-619-28",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28) ",
"NDC11Code": "68382-0619-28",
"ProductNDC": "68382-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam",
"NonProprietaryName": "Colesevelam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207765",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191011",
"SamplePackage": "N",
"IndicationAndUsage": "Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).",
"Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets)."
},
{
"NDCCode": "68382-619-77",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30) ",
"NDC11Code": "68382-0619-77",
"ProductNDC": "68382-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam",
"NonProprietaryName": "Colesevelam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191011",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207765",
"LabelerName": "Zydus Pharmaceuticals USA Inc.",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191011",
"SamplePackage": "N",
"IndicationAndUsage": "Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).",
"Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets)."
},
{
"NDCCode": "70121-1572-1",
"PackageDescription": "1 VIAL in 1 CARTON (70121-1572-1) / 17.5 mL in 1 VIAL",
"NDC11Code": "70121-1572-01",
"ProductNDC": "70121-1572",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levoleucovorin Calcium",
"NonProprietaryName": "Levoleucovorin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20170908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207548",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LEVOLEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2024-08-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170908",
"SamplePackage": "N",
"IndicationAndUsage": "Levoleucovorin injection is indicated for: 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma., 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients., 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil.",
"Description": "Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular formula is C20H21CaN7O7 nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin injection, for intravenous use is supplied as a sterile clear yellow color solution of 175 mg levoleucovorin in 17.5 mL per single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates (equivalent to 10 mg levoleucovorin) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.1 (6.5 to 8.5)."
},
{
"NDCCode": "71288-105-18",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0105-18",
"ProductNDC": "71288-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levoleucovorin",
"NonProprietaryName": "Levoleucovorin Calcium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211002",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "LEVOLEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190816",
"SamplePackage": "N",
"IndicationAndUsage": "Levoleucovorin Injection is indicated for: : 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. , 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. , 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. .",
"Description": "Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular formula is C20H21CaN7O7 ● nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin Injection, for intravenous use is supplied as a sterile colorless to yellow, clear solution of either 175 mg levoleucovorin in 17.5 mL or 250 mg levoleucovorin in 25 mL per single-dose vial. Each mL contains 10 mg levoleucovorin (equivalent to 10.8 mg levoleucovorin calcium, on anhydrous basis) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.0 (6.5 to 8.5)."
},
{
"NDCCode": "71288-105-25",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "71288-0105-25",
"ProductNDC": "71288-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levoleucovorin",
"NonProprietaryName": "Levoleucovorin Calcium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211002",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "LEVOLEUCOVORIN CALCIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog [EPC], Folic Acid [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190816",
"SamplePackage": "N",
"IndicationAndUsage": "Levoleucovorin Injection is indicated for: : 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. , 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. , 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. .",
"Description": "Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular formula is C20H21CaN7O7 ● nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin Injection, for intravenous use is supplied as a sterile colorless to yellow, clear solution of either 175 mg levoleucovorin in 17.5 mL or 250 mg levoleucovorin in 25 mL per single-dose vial. Each mL contains 10 mg levoleucovorin (equivalent to 10.8 mg levoleucovorin calcium, on anhydrous basis) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.0 (6.5 to 8.5)."
},
{
"NDCCode": "71610-619-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (71610-619-53) ",
"NDC11Code": "71610-0619-53",
"ProductNDC": "71610-619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208677",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211202",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "75936-619-02",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (75936-619-02) / 3.5 g in 1 TUBE, WITH APPLICATOR (75936-619-01) ",
"NDC11Code": "75936-0619-02",
"ProductNDC": "75936-619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lipshade Spf 30 Obsessed",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230413",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Supergoop, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "17.5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230413",
"SamplePackage": "N"
},
{
"NDCCode": "84682-619-01",
"PackageDescription": "50 g in 1 BOX (84682-619-01) ",
"NDC11Code": "84682-0619-01",
"ProductNDC": "84682-619",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Darek Spot Cream",
"NonProprietaryName": "Trstay Darek Spot Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241024",
"EndMarketingDate": "20311031",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Yucheng E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20241024",
"EndMarketingDatePackage": "20311031",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84440-003-10",
"PackageDescription": "1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE",
"NDC11Code": "84440-0003-10",
"ProductNDC": "84440-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biocorneum",
"NonProprietaryName": "Avobenzone, Homosalate, Meradimate, Octisalate, And Octocrylene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 50; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
},
{
"NDCCode": "84440-003-20",
"PackageDescription": "1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE",
"NDC11Code": "84440-0003-20",
"ProductNDC": "84440-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biocorneum",
"NonProprietaryName": "Avobenzone, Homosalate, Meradimate, Octisalate, And Octocrylene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 50; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
},
{
"NDCCode": "84440-003-50",
"PackageDescription": "1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE",
"NDC11Code": "84440-0003-50",
"ProductNDC": "84440-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biocorneum",
"NonProprietaryName": "Avobenzone, Homosalate, Meradimate, Octisalate, And Octocrylene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30; 150; 50; 50; 100",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2024-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
},
{
"NDCCode": "84440-608-01",
"PackageDescription": "1 g in 1 TUBE (84440-608-01) ",
"NDC11Code": "84440-0608-01",
"ProductNDC": "84440-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pro-sil Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "Y",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS."
},
{
"NDCCode": "84440-608-42",
"PackageDescription": "4.25 g in 1 TUBE (84440-608-42) ",
"NDC11Code": "84440-0608-42",
"ProductNDC": "84440-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pro-sil Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS."
},
{
"NDCCode": "84440-626-01",
"PackageDescription": "1 g in 1 TUBE (84440-626-01) ",
"NDC11Code": "84440-0626-01",
"ProductNDC": "84440-626",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scaraid Us Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "Y",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS."
},
{
"NDCCode": "84440-626-42",
"PackageDescription": "4.25 g in 1 TUBE (84440-626-42) ",
"NDC11Code": "84440-0626-42",
"ProductNDC": "84440-626",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scaraid Us Spf",
"NonProprietaryName": "Silicone Stick With Spf",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Biodermis, LLC",
"SubstanceName": "OCTINOXATE; AVOBENZONE; OCTOCRYLENE",
"StrengthNumber": "40; 30; 50",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.",
"Description": "PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>84440-619-17</NDCCode>
<PackageDescription>17 g in 1 TUBE (84440-619-17) </PackageDescription>
<NDC11Code>84440-0619-17</NDC11Code>
<ProductNDC>84440-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scaraid Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLYDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-608-17</NDCCode>
<PackageDescription>17 g in 1 TUBE (84440-608-17) </PackageDescription>
<NDC11Code>84440-0608-17</NDC11Code>
<ProductNDC>84440-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pro-sil Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-626-17</NDCCode>
<PackageDescription>17 g in 1 TUBE (84440-626-17) </PackageDescription>
<NDC11Code>84440-0626-17</NDC11Code>
<ProductNDC>84440-626</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scaraid Us Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-619-01</NDCCode>
<PackageDescription>1 g in 1 TUBE (84440-619-01) </PackageDescription>
<NDC11Code>84440-0619-01</NDC11Code>
<ProductNDC>84440-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scaraid Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLYDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-619-42</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (84440-619-42) </PackageDescription>
<NDC11Code>84440-0619-42</NDC11Code>
<ProductNDC>84440-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scaraid Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLYDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>43269-619-17</NDCCode>
<PackageDescription>517 mL in 1 BOTTLE (43269-619-17)</PackageDescription>
<NDC11Code>43269-0619-17</NDC11Code>
<ProductNDC>43269-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mango Spice Antibacterial Foaming Handwash</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100623</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65841-619-17</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE (65841-619-17) </PackageDescription>
<NDC11Code>65841-0619-17</NDC11Code>
<ProductNDC>65841-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077614</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61919-619-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (61919-619-15) </PackageDescription>
<NDC11Code>61919-0619-15</NDC11Code>
<ProductNDC>61919-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA087385</ApplicationNumber>
<LabelerName>DIRECTRX</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
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<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. [chemstructure]. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
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<IndicationAndUsage>Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
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<IndicationAndUsage>Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
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<IndicationAndUsage>Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
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<IndicationAndUsage>Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
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<IndicationAndUsage>Hypertension Quinapril tablets, USP 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with quinapril tablets, USP. 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. Quinapril tablets, USP may be used alone or in combination with thiazide diuretics. Heart Failure Quinapril tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. In using quinapril tablets, USP consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease. Available data are insufficient to show that quinapril tablets, USP do not have a similar risk (see WARNINGS). Angioedema in black patients: Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks.</IndicationAndUsage>
<Description>Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its molecular formula is C25H30N2O5HCl and its structural formula is:. Quinapril hydrochloride USP is a white to off-white powder, with a pink cast at times that is freely soluble in aqueous solvents. Quinapril tablets, USP contain 5 mg (equivalent to 5.416 mg quinapril hydrochloride), 10 mg (equivalent to 10.832 mg quinapril hydrochloride), 20 mg (equivalent to 21.664 mg quinapril hydrochloride), or 40 mg (equivalent to 43.328 mg quinapril hydrochloride) of quinapril for oral administration. Each tablet also contains colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide red, lactose monohydrate, magnesium carbonate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207765</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).</IndicationAndUsage>
<Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets).</Description>
</NDC>
<NDC>
<NDCCode>68382-619-28</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28) </PackageDescription>
<NDC11Code>68382-0619-28</NDC11Code>
<ProductNDC>68382-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colesevelam</ProprietaryName>
<NonProprietaryName>Colesevelam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207765</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).</IndicationAndUsage>
<Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets).</Description>
</NDC>
<NDC>
<NDCCode>68382-619-77</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30) </PackageDescription>
<NDC11Code>68382-0619-77</NDC11Code>
<ProductNDC>68382-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colesevelam</ProprietaryName>
<NonProprietaryName>Colesevelam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191011</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207765</ApplicationNumber>
<LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).</IndicationAndUsage>
<Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is a polymer with off-white to light yellow color powder, which is insoluble in water and any organic solvent. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross- linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablet contains 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide yellow, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, sodium bicarbonate. The tablet is printed with black pharmaceutical ink which contains ammonium hydroxide, ferrosoferric oxide, propylene glycol and shellac (< 5 calories per 6 tablets).</Description>
</NDC>
<NDC>
<NDCCode>70121-1572-1</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (70121-1572-1) / 17.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>70121-1572-01</NDC11Code>
<ProductNDC>70121-1572</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levoleucovorin Calcium</ProprietaryName>
<NonProprietaryName>Levoleucovorin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20170908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207548</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LEVOLEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levoleucovorin injection is indicated for: 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma., 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients., 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil.</IndicationAndUsage>
<Description>Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular formula is C20H21CaN7O7 nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin injection, for intravenous use is supplied as a sterile clear yellow color solution of 175 mg levoleucovorin in 17.5 mL per single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates (equivalent to 10 mg levoleucovorin) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.1 (6.5 to 8.5).</Description>
</NDC>
<NDC>
<NDCCode>71288-105-18</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0105-18</NDC11Code>
<ProductNDC>71288-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levoleucovorin</ProprietaryName>
<NonProprietaryName>Levoleucovorin Calcium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211002</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEVOLEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levoleucovorin Injection is indicated for: : 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. , 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. , 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. .</IndicationAndUsage>
<Description>Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular formula is C20H21CaN7O7 ● nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin Injection, for intravenous use is supplied as a sterile colorless to yellow, clear solution of either 175 mg levoleucovorin in 17.5 mL or 250 mg levoleucovorin in 25 mL per single-dose vial. Each mL contains 10 mg levoleucovorin (equivalent to 10.8 mg levoleucovorin calcium, on anhydrous basis) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.0 (6.5 to 8.5).</Description>
</NDC>
<NDC>
<NDCCode>71288-105-25</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>71288-0105-25</NDC11Code>
<ProductNDC>71288-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levoleucovorin</ProprietaryName>
<NonProprietaryName>Levoleucovorin Calcium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211002</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEVOLEUCOVORIN CALCIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Folate Analog [EPC], Folic Acid [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levoleucovorin Injection is indicated for: : 1 rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. , 2 diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. , 3 the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. .</IndicationAndUsage>
<Description>Levoleucovorin is a folate analog and the pharmacologically active levo-isomer of d,l-leucovorin. The chemical name of levoleucovorin calcium is calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular formula is C20H21CaN7O7 ● nH2O (n = 3 to 6) and the molecular weight is 565.6 to 619.6. The molecular structure is. Levoleucovorin Injection, for intravenous use is supplied as a sterile colorless to yellow, clear solution of either 175 mg levoleucovorin in 17.5 mL or 250 mg levoleucovorin in 25 mL per single-dose vial. Each mL contains 10 mg levoleucovorin (equivalent to 10.8 mg levoleucovorin calcium, on anhydrous basis) and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.0 (6.5 to 8.5).</Description>
</NDC>
<NDC>
<NDCCode>71610-619-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (71610-619-53) </PackageDescription>
<NDC11Code>71610-0619-53</NDC11Code>
<ProductNDC>71610-619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208677</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline powder with a pKa1 of 4.2 and a pKa2 of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>75936-619-02</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (75936-619-02) / 3.5 g in 1 TUBE, WITH APPLICATOR (75936-619-01) </PackageDescription>
<NDC11Code>75936-0619-02</NDC11Code>
<ProductNDC>75936-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lipshade Spf 30 Obsessed</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Supergoop, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>17.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>84682-619-01</NDCCode>
<PackageDescription>50 g in 1 BOX (84682-619-01) </PackageDescription>
<NDC11Code>84682-0619-01</NDC11Code>
<ProductNDC>84682-619</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Darek Spot Cream</ProprietaryName>
<NonProprietaryName>Trstay Darek Spot Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241024</StartMarketingDate>
<EndMarketingDate>20311031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Yucheng E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20241024</StartMarketingDatePackage>
<EndMarketingDatePackage>20311031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84440-003-10</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE</PackageDescription>
<NDC11Code>84440-0003-10</NDC11Code>
<ProductNDC>84440-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biocorneum</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Meradimate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 50; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84440-003-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>84440-0003-20</NDC11Code>
<ProductNDC>84440-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biocorneum</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Meradimate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 50; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84440-003-50</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE</PackageDescription>
<NDC11Code>84440-0003-50</NDC11Code>
<ProductNDC>84440-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biocorneum</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Meradimate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 150; 50; 50; 100</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84440-608-01</NDCCode>
<PackageDescription>1 g in 1 TUBE (84440-608-01) </PackageDescription>
<NDC11Code>84440-0608-01</NDC11Code>
<ProductNDC>84440-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pro-sil Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-608-42</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (84440-608-42) </PackageDescription>
<NDC11Code>84440-0608-42</NDC11Code>
<ProductNDC>84440-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pro-sil Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-626-01</NDCCode>
<PackageDescription>1 g in 1 TUBE (84440-626-01) </PackageDescription>
<NDC11Code>84440-0626-01</NDC11Code>
<ProductNDC>84440-626</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scaraid Us Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
<NDC>
<NDCCode>84440-626-42</NDCCode>
<PackageDescription>4.25 g in 1 TUBE (84440-626-42) </PackageDescription>
<NDC11Code>84440-0626-42</NDC11Code>
<ProductNDC>84440-626</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scaraid Us Spf</ProprietaryName>
<NonProprietaryName>Silicone Stick With Spf</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Biodermis, LLC</LabelerName>
<SubstanceName>OCTINOXATE; AVOBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>40; 30; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SILICONE STICK FOR SCARS. BROAD SPECTRUM UVA/UVB SUNSCREEN. HELPS PREVENT SUNBURN.</IndicationAndUsage>
<Description>PROSIL SPF15. SILICONE STICK FOR SCARS. GLIDE-ON THERAPY FOR YOUR SCARS.</Description>
</NDC>
</NDCList>