{
"NDC": [
{
"NDCCode": "69452-175-17",
"PackageDescription": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17) ",
"NDC11Code": "69452-0175-17",
"ProductNDC": "69452-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omega-3-acid Ethyl Ester",
"NonProprietaryName": "Omega-3-acid Ethyl Esters",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206455",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
"StrengthNumber": "900",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170115",
"SamplePackage": "N",
"IndicationAndUsage": "Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.",
"Description": "Omega-3-acid ethyl esters, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The empirical formula of EPA ethyl ester is C 22H 34O 2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The empirical formula of DHA ethyl ester is C 24H 36O 2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:. Omega-3-acid ethyl esters capsules, USP also contain 4 mg alpha-tocopherol as an inactive ingredient in the capsule fill. The capsule shell is composed of gelatin, glycerin and water. The capsules are printed with white ink composed of hypromellose, isopropyl alcohol, propylene glycol, titanium dioxide and water."
},
{
"NDCCode": "69452-175-22",
"PackageDescription": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22) ",
"NDC11Code": "69452-0175-22",
"ProductNDC": "69452-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omega-3-acid Ethyl Ester",
"NonProprietaryName": "Omega-3-acid Ethyl Esters",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206455",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "OMEGA-3-ACID ETHYL ESTERS",
"StrengthNumber": "900",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]",
"Status": "Active",
"LastUpdate": "2021-05-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170115",
"SamplePackage": "N",
"IndicationAndUsage": "Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.",
"Description": "Omega-3-acid ethyl esters, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The empirical formula of EPA ethyl ester is C 22H 34O 2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The empirical formula of DHA ethyl ester is C 24H 36O 2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:. Omega-3-acid ethyl esters capsules, USP also contain 4 mg alpha-tocopherol as an inactive ingredient in the capsule fill. The capsule shell is composed of gelatin, glycerin and water. The capsules are printed with white ink composed of hypromellose, isopropyl alcohol, propylene glycol, titanium dioxide and water."
},
{
"NDCCode": "16729-175-17",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-175-17) ",
"NDC11Code": "16729-0175-17",
"ProductNDC": "16729-175",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141205",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20240101",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N"
},
{
"NDCCode": "63776-175-17",
"PackageDescription": "250 mL in 1 BOTTLE (63776-175-17) ",
"NDC11Code": "63776-0175-17",
"ProductNDC": "63776-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-f Gus",
"NonProprietaryName": "Berberis, Cochlerearia Armor, Echinacea, Ferrum, Hydrastis, Iridium, Lapacho, Lomatium, Lycopodium, Myrrh, Phosporicum Acidum, Propolis, Pulsatilla, Seleneium, Thymus, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANEMONE PULSATILLA; ARMORACIA RUSTICANA WHOLE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HANDROANTHUS IMPETIGINOSUS WHOLE; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; SELENIUM; SUS SCROFA THYMUS; ZINC",
"StrengthNumber": "12; 3; 3; 6; 3; 3; 3; 12; 12; 3; 12; 3; 12; 3; 12; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "nutritional support for fungal, mold, bacteria challenges.",
"Description": "Viatrexx-F gus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "67417-231-17",
"PackageDescription": "175 kg in 1 DRUM (67417-231-17)",
"NDC11Code": "67417-0231-17",
"ProductNDC": "67417-231",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Carbonate Dc",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20150518",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "92.5",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "67417-241-17",
"PackageDescription": "175 kg in 1 DRUM (67417-241-17) ",
"NDC11Code": "67417-0241-17",
"ProductNDC": "67417-241",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Calcium Carbonate Dc",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20200128",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "90",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2026-08-06",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "28-JAN-20"
},
{
"NDCCode": "67430-175-17",
"PackageDescription": "275 kg in 1 DRUM (67430-175-17) ",
"NDC11Code": "67430-0175-17",
"ProductNDC": "67430-175",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Lactate",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20170123",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pfanstiehl, Inc.",
"SubstanceName": "SODIUM LACTATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-JAN-17"
},
{
"NDCCode": "69848-003-17",
"PackageDescription": "175 TABLET in 1 BOTTLE (69848-003-17) ",
"NDC11Code": "69848-0003-17",
"ProductNDC": "69848-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Granules USA, Inc",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "■ temporarily relieves minor aches and pains due to. ■ the common cold. ■ headache. ■ backache. ■ minor pain of arthritis. ■ toothache. ■ muscular aches. ■ premenstrual and menstrual cramps. ■ temporarily reduces fever."
},
{
"NDCCode": "74541-175-17",
"PackageDescription": "500 mL in 1 BOTTLE, DISPENSING (74541-175-17) ",
"NDC11Code": "74541-0175-17",
"ProductNDC": "74541-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Inflatables LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "74543-175-17",
"PackageDescription": "500 mL in 1 BOTTLE, DISPENSING (74543-175-17) ",
"NDC11Code": "74543-0175-17",
"ProductNDC": "74543-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Margrey Industrial, S.A. de C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "83602-175-17",
"PackageDescription": "17 BAG in 1 BOX (83602-175-17) / 1 PATCH in 1 BAG / 21 g in 1 PATCH (83602-175-01) ",
"NDC11Code": "83602-0175-17",
"ProductNDC": "83602-175",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief Gel-patch",
"NonProprietaryName": "Lidocaine And Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.",
"SubstanceName": "MENTHOL; LIDOCAINE",
"StrengthNumber": ".01; .04",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, neck, shoulders, elbows."
},
{
"NDCCode": "69452-131-17",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (69452-131-17) ",
"NDC11Code": "69452-0131-17",
"ProductNDC": "69452-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208625",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180411",
"SamplePackage": "N",
"IndicationAndUsage": "Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "69452-132-17",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (69452-132-17) ",
"NDC11Code": "69452-0132-17",
"ProductNDC": "69452-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208625",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180411",
"SamplePackage": "N",
"IndicationAndUsage": "Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "69452-133-17",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (69452-133-17) ",
"NDC11Code": "69452-0133-17",
"ProductNDC": "69452-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dofetilide",
"NonProprietaryName": "Dofetilide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208625",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "DOFETILIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2023-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180411",
"SamplePackage": "N",
"IndicationAndUsage": "Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).",
"Description": "Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules."
},
{
"NDCCode": "69452-190-17",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17) ",
"NDC11Code": "69452-0190-17",
"ProductNDC": "69452-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213276",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"Description": "Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I f current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7 S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C 27H 36N 2O 5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure1.Chemical Structure ofIvabradine. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: corn starch, croscarmellose sodium, glycerol monocaprylocaprate, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol–polyvinyl alcohol grafted copolymer, talc, and titanium dioxide."
},
{
"NDCCode": "69452-191-17",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (69452-191-17) ",
"NDC11Code": "69452-0191-17",
"ProductNDC": "69452-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ivabradine",
"NonProprietaryName": "Ivabradine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213276",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "IVABRADINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250301",
"SamplePackage": "N",
"Description": "Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I f current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7 S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C 27H 36N 2O 5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure1.Chemical Structure ofIvabradine. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: corn starch, croscarmellose sodium, glycerol monocaprylocaprate, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol–polyvinyl alcohol grafted copolymer, talc, and titanium dioxide."
},
{
"NDCCode": "69452-255-17",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (69452-255-17) ",
"NDC11Code": "69452-0255-17",
"ProductNDC": "69452-255",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etravirine",
"NonProprietaryName": "Etravirine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219152",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "ETRAVIRINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260101",
"SamplePackage": "N",
"IndicationAndUsage": "Etravirine tablets in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4)and Clinical Studies (14)] .",
"Description": "Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl) amino]-4-pyrimidinyl] oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C 20H 15BrN 6O and its molecular weight is 435.29 g/mol. Etravirine, USP has the following structural formula:. Etravirine, USP is an off-white to pale yellow powder. Etravirine, USP is soluble in acetone. Etravirine tablets, USP 100 mg are available as off-white to pale-yellow, slightly mottled oval-shaped tablets for oral administration. Each 100 mg tablet contains 100 mg of etravirine, USP and the inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. Etravirine tablets, USP 200 mg are available as off-white to pale-yellow, slightly mottled oval-shaped tablets for oral administration. Each 200 mg tablet contains 200 mg of etravirine, USP and the inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "69452-283-17",
"PackageDescription": "1 BOTTLE in 1 CARTON (69452-283-17) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "69452-0283-17",
"ProductNDC": "69452-283",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Loratadine",
"NonProprietaryName": "Loratadine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202538",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "LORATADINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20210826",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "69452-427-17",
"PackageDescription": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-17) ",
"NDC11Code": "69452-0427-17",
"ProductNDC": "69452-427",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nighttime Sleep-aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20240321",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "BIONPHARMA INC.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240321",
"SamplePackage": "N",
"IndicationAndUsage": "For relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "69452-508-17",
"PackageDescription": "60 TABLET in 1 BOTTLE (69452-508-17) ",
"NDC11Code": "69452-0508-17",
"ProductNDC": "69452-508",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216187",
"LabelerName": "BIONPHARMA INC.",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251028",
"SamplePackage": "N",
"IndicationAndUsage": "Ticagrelor tablets are a P2Y 12platelet inhibitor indicated : 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2) , 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3) .",
"Description": "Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor tablets, 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. Ticagrelor tablets, 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red."
},
{
"NDCCode": "69452-509-17",
"PackageDescription": "60 TABLET in 1 BOTTLE (69452-509-17) ",
"NDC11Code": "69452-0509-17",
"ProductNDC": "69452-509",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20251028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216187",
"LabelerName": "BIONPHARMA INC.",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251028",
"SamplePackage": "N",
"IndicationAndUsage": "Ticagrelor tablets are a P2Y 12platelet inhibitor indicated : 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2) , 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3) .",
"Description": "Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor tablets, 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. Ticagrelor tablets, 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red."
},
{
"NDCCode": "69452-573-17",
"PackageDescription": "60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-573-17) ",
"NDC11Code": "69452-0573-17",
"ProductNDC": "69452-573",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dextromethorphan Hbr",
"NonProprietaryName": "Dextromethorphan Hbr",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20260831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "BIONPHARMA INC.",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260831",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold."
},
{
"NDCCode": "69452-143-20",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20) ",
"NDC11Code": "69452-0143-20",
"ProductNDC": "69452-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081297",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160815",
"SamplePackage": "N",
"IndicationAndUsage": "BENZONATATE is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water."
},
{
"NDCCode": "69452-143-30",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30) ",
"NDC11Code": "69452-0143-30",
"ProductNDC": "69452-143",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081297",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160815",
"SamplePackage": "N",
"IndicationAndUsage": "BENZONATATE is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water."
},
{
"NDCCode": "69452-144-20",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-20) ",
"NDC11Code": "69452-0144-20",
"ProductNDC": "69452-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081297",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160815",
"SamplePackage": "N",
"IndicationAndUsage": "BENZONATATE is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water."
},
{
"NDCCode": "69452-144-30",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-30) ",
"NDC11Code": "69452-0144-30",
"ProductNDC": "69452-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081297",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160815",
"SamplePackage": "N",
"IndicationAndUsage": "BENZONATATE is indicated for the symptomatic relief of cough.",
"Description": "Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water."
},
{
"NDCCode": "69452-153-20",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-153-20) ",
"NDC11Code": "69452-0153-20",
"ProductNDC": "69452-153",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090802",
"LabelerName": "BionPharma Inc.,",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160226",
"SamplePackage": "N",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules, USP are available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide . The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide."
},
{
"NDCCode": "69452-154-20",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-154-20) ",
"NDC11Code": "69452-0154-20",
"ProductNDC": "69452-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090802",
"LabelerName": "BionPharma Inc.,",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160226",
"SamplePackage": "N",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules, USP are available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide . The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide."
},
{
"NDCCode": "69452-155-20",
"PackageDescription": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-155-20) ",
"NDC11Code": "69452-0155-20",
"ProductNDC": "69452-155",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090802",
"LabelerName": "BionPharma Inc.,",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160226",
"SamplePackage": "N",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules, USP are available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide . The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide."
},
{
"NDCCode": "69452-156-73",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (69452-156-73) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (69452-156-74) ",
"NDC11Code": "69452-0156-73",
"ProductNDC": "69452-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizatriptan Benzoate",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20170117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204722",
"LabelerName": "Bionpharma Inc.,",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2021-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170117",
"SamplePackage": "N",
"IndicationAndUsage": "Rizatriptan Benzoate Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks., 2 Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of Rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.",
"Description": "Rizatriptan Benzoate Orally Disintegrating Tablet contains rizatriptan benzoate, a selective 5-hydroxytryptamine (5- 1B/1D HT ) receptor agonist. Rizatriptan benzoate is described 1B/1D chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan Benzoate is a white to off-white crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, colloidal silicon dioxide, xylitol, anhydrous dibasic calcium phosphate, crospovidone, mannitol, sodium stearyl fumarate, aspartame, isopropyl alcohol and menthol."
}
]
}
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<NDCList>
<NDC>
<NDCCode>69452-175-17</NDCCode>
<PackageDescription>60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-17) </PackageDescription>
<NDC11Code>69452-0175-17</NDC11Code>
<ProductNDC>69452-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omega-3-acid Ethyl Ester</ProprietaryName>
<NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206455</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>OMEGA-3-ACID ETHYL ESTERS</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.</IndicationAndUsage>
<Description>Omega-3-acid ethyl esters, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The empirical formula of EPA ethyl ester is C 22H 34O 2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The empirical formula of DHA ethyl ester is C 24H 36O 2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:. Omega-3-acid ethyl esters capsules, USP also contain 4 mg alpha-tocopherol as an inactive ingredient in the capsule fill. The capsule shell is composed of gelatin, glycerin and water. The capsules are printed with white ink composed of hypromellose, isopropyl alcohol, propylene glycol, titanium dioxide and water.</Description>
</NDC>
<NDC>
<NDCCode>69452-175-22</NDCCode>
<PackageDescription>120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-175-22) </PackageDescription>
<NDC11Code>69452-0175-22</NDC11Code>
<ProductNDC>69452-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omega-3-acid Ethyl Ester</ProprietaryName>
<NonProprietaryName>Omega-3-acid Ethyl Esters</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206455</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>OMEGA-3-ACID ETHYL ESTERS</SubstanceName>
<StrengthNumber>900</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of TG-lowering drug therapy. Limitations of Use:. The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined.</IndicationAndUsage>
<Description>Omega-3-acid ethyl esters, a lipid-regulating agent, are supplied as a liquid-filled gel capsule for oral administration. Each 1 gram capsule of omega-3-acid ethyl esters contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg). The empirical formula of EPA ethyl ester is C 22H 34O 2, and the molecular weight of EPA ethyl ester is 330.51. The structural formula of EPA ethyl ester is:. The empirical formula of DHA ethyl ester is C 24H 36O 2, and the molecular weight of DHA ethyl ester is 356.55. The structural formula of DHA ethyl ester is:. Omega-3-acid ethyl esters capsules, USP also contain 4 mg alpha-tocopherol as an inactive ingredient in the capsule fill. The capsule shell is composed of gelatin, glycerin and water. The capsules are printed with white ink composed of hypromellose, isopropyl alcohol, propylene glycol, titanium dioxide and water.</Description>
</NDC>
<NDC>
<NDCCode>16729-175-17</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16729-175-17) </PackageDescription>
<NDC11Code>16729-0175-17</NDC11Code>
<ProductNDC>16729-175</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141205</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63776-175-17</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE (63776-175-17) </PackageDescription>
<NDC11Code>63776-0175-17</NDC11Code>
<ProductNDC>63776-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-f Gus</ProprietaryName>
<NonProprietaryName>Berberis, Cochlerearia Armor, Echinacea, Ferrum, Hydrastis, Iridium, Lapacho, Lomatium, Lycopodium, Myrrh, Phosporicum Acidum, Propolis, Pulsatilla, Seleneium, Thymus, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANEMONE PULSATILLA; ARMORACIA RUSTICANA WHOLE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS THYMUS; ECHINACEA ANGUSTIFOLIA; GOLDENSEAL; HANDROANTHUS IMPETIGINOSUS WHOLE; IRIDIUM; IRON; LOMATIUM DISSECTUM ROOT; LYCOPODIUM CLAVATUM SPORE; MYRRH; PHOSPHORIC ACID; PROPOLIS WAX; SELENIUM; SUS SCROFA THYMUS; ZINC</SubstanceName>
<StrengthNumber>12; 3; 3; 6; 3; 3; 3; 12; 12; 3; 12; 3; 12; 3; 12; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>nutritional support for fungal, mold, bacteria challenges.</IndicationAndUsage>
<Description>Viatrexx-F gus is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>67417-231-17</NDCCode>
<PackageDescription>175 kg in 1 DRUM (67417-231-17)</PackageDescription>
<NDC11Code>67417-0231-17</NDC11Code>
<ProductNDC>67417-231</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcium Carbonate Dc</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20150518</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>92.5</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67417-241-17</NDCCode>
<PackageDescription>175 kg in 1 DRUM (67417-241-17) </PackageDescription>
<NDC11Code>67417-0241-17</NDC11Code>
<ProductNDC>67417-241</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Calcium Carbonate Dc</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20200128</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-08-06</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>28-JAN-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67430-175-17</NDCCode>
<PackageDescription>275 kg in 1 DRUM (67430-175-17) </PackageDescription>
<NDC11Code>67430-0175-17</NDC11Code>
<ProductNDC>67430-175</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Lactate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20170123</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pfanstiehl, Inc.</LabelerName>
<SubstanceName>SODIUM LACTATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-JAN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69848-003-17</NDCCode>
<PackageDescription>175 TABLET in 1 BOTTLE (69848-003-17) </PackageDescription>
<NDC11Code>69848-0003-17</NDC11Code>
<ProductNDC>69848-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Granules USA, Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ temporarily relieves minor aches and pains due to. ■ the common cold. ■ headache. ■ backache. ■ minor pain of arthritis. ■ toothache. ■ muscular aches. ■ premenstrual and menstrual cramps. ■ temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74541-175-17</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, DISPENSING (74541-175-17) </PackageDescription>
<NDC11Code>74541-0175-17</NDC11Code>
<ProductNDC>74541-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Inflatables LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74543-175-17</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, DISPENSING (74543-175-17) </PackageDescription>
<NDC11Code>74543-0175-17</NDC11Code>
<ProductNDC>74543-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Margrey Industrial, S.A. de C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83602-175-17</NDCCode>
<PackageDescription>17 BAG in 1 BOX (83602-175-17) / 1 PATCH in 1 BAG / 21 g in 1 PATCH (83602-175-01) </PackageDescription>
<NDC11Code>83602-0175-17</NDC11Code>
<ProductNDC>83602-175</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief Gel-patch</ProprietaryName>
<NonProprietaryName>Lidocaine And Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.</LabelerName>
<SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
<StrengthNumber>.01; .04</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, neck, shoulders, elbows.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69452-131-17</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (69452-131-17) </PackageDescription>
<NDC11Code>69452-0131-17</NDC11Code>
<ProductNDC>69452-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208625</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>69452-132-17</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (69452-132-17) </PackageDescription>
<NDC11Code>69452-0132-17</NDC11Code>
<ProductNDC>69452-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208625</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>69452-133-17</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (69452-133-17) </PackageDescription>
<NDC11Code>69452-0133-17</NDC11Code>
<ProductNDC>69452-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dofetilide</ProprietaryName>
<NonProprietaryName>Dofetilide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208625</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>DOFETILIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dofetilide capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES).</IndicationAndUsage>
<Description>Dofetilide is an antiarrhythmic drug with Class III (cardiac action potential duration prolonging) properties. Its empirical formula is C 19H 27N 3O 5S 2 and it has a molecular weight of 441.6. The structural formula is. The chemical name for dofetilide is. N-[4-[2-[methyl[2-[4-[(methylsulfonyl) amino] phenoxy] ethyl] amino] ethyl] phenyl]‑methanesulfonamide. Dofetilide is a white to off-white powder. It is very slightly soluble in water and propan‑2‑ol and is soluble in 0.1M aqueous sodium hydroxide, acetone, and aqueous 0.1M hydrochloric acid. Dofetilide capsules contain the following inactive ingredients: microcrystalline cellulose, corn starch, colloidal silicon dioxide and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, FD&C yellow 6 and black imprint ink. The black imprint ink contains shellac, alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia solution, black iron oxide and potassium hydroxide. Dofetilide capsules are supplied for oral administration in three dosage strengths: 125 mcg (0.125 mg) orange and white capsules, 250 mcg (0.25 mg) peach capsules, and 500 mcg (0.5 mg) peach and white capsules.</Description>
</NDC>
<NDC>
<NDCCode>69452-190-17</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (69452-190-17) </PackageDescription>
<NDC11Code>69452-0190-17</NDC11Code>
<ProductNDC>69452-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213276</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I f current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7 S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C 27H 36N 2O 5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure1.Chemical Structure ofIvabradine. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: corn starch, croscarmellose sodium, glycerol monocaprylocaprate, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol–polyvinyl alcohol grafted copolymer, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69452-191-17</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (69452-191-17) </PackageDescription>
<NDC11Code>69452-0191-17</NDC11Code>
<ProductNDC>69452-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ivabradine</ProprietaryName>
<NonProprietaryName>Ivabradine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213276</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>IVABRADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ivabradine tablets contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I f current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7 S)-3,4-Dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl] methyl amino} propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2H-3-benzazepin-2-one, hydrochloride. The molecular formula is C 27H 36N 2O 5·HCl, and the molecular weight (free base + HCl) is 505.1 (468.6 + 36.5). The chemical structure of ivabradine is shown in Figure 1. Figure1.Chemical Structure ofIvabradine. Ivabradine tablets are supplied in 5 mg and 7.5 mg tablets for oral administration. The tablets contain 5 mg and 7.5 mg of ivabradine, as the active ingredient, equivalent to 5.39 mg and 8.09 mg of ivabradine hydrochloride, respectively. The tablets contain the following inactive ingredients: corn starch, croscarmellose sodium, glycerol monocaprylocaprate, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol–polyvinyl alcohol grafted copolymer, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69452-255-17</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (69452-255-17) </PackageDescription>
<NDC11Code>69452-0255-17</NDC11Code>
<ProductNDC>69452-255</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etravirine</ProprietaryName>
<NonProprietaryName>Etravirine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219152</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>ETRAVIRINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Etravirine tablets in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and pediatric patients 2 years of age and older [see Microbiology (12.4)and Clinical Studies (14)] .</IndicationAndUsage>
<Description>Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl) amino]-4-pyrimidinyl] oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C 20H 15BrN 6O and its molecular weight is 435.29 g/mol. Etravirine, USP has the following structural formula:. Etravirine, USP is an off-white to pale yellow powder. Etravirine, USP is soluble in acetone. Etravirine tablets, USP 100 mg are available as off-white to pale-yellow, slightly mottled oval-shaped tablets for oral administration. Each 100 mg tablet contains 100 mg of etravirine, USP and the inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. Etravirine tablets, USP 200 mg are available as off-white to pale-yellow, slightly mottled oval-shaped tablets for oral administration. Each 200 mg tablet contains 200 mg of etravirine, USP and the inactive ingredients colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>69452-283-17</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (69452-283-17) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>69452-0283-17</NDC11Code>
<ProductNDC>69452-283</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Loratadine</ProprietaryName>
<NonProprietaryName>Loratadine</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200320</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202538</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>LORATADINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69452-427-17</NDCCode>
<PackageDescription>60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-427-17) </PackageDescription>
<NDC11Code>69452-0427-17</NDC11Code>
<ProductNDC>69452-427</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nighttime Sleep-aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>BIONPHARMA INC.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69452-508-17</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69452-508-17) </PackageDescription>
<NDC11Code>69452-0508-17</NDC11Code>
<ProductNDC>69452-508</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216187</ApplicationNumber>
<LabelerName>BIONPHARMA INC.</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet inhibitor indicated : 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2) , 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3) .</IndicationAndUsage>
<Description>Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor tablets, 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. Ticagrelor tablets, 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>69452-509-17</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69452-509-17) </PackageDescription>
<NDC11Code>69452-0509-17</NDC11Code>
<ProductNDC>69452-509</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216187</ApplicationNumber>
<LabelerName>BIONPHARMA INC.</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ticagrelor tablets are a P2Y 12platelet inhibitor indicated : 1 to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS (1.1), 2 to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2) , 3 to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3) .</IndicationAndUsage>
<Description>Ticagrelor tablets contain ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y 12ADP-receptor. Chemically it is (1 S,2 S,3 R,5 S)-3-[7-{[(1 R,2 S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3 H-[1,2,3]-triazolo[4,5- d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C 23H 28F 2N 6O 4S and its molecular weight is 522.57. The chemical structure of ticagrelor is:. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor tablets, 90 mg for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, polyethylene glycol 400, and ferric oxide yellow. Ticagrelor tablets, 60 mg for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol 400, ferric oxide black, and ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>69452-573-17</NDCCode>
<PackageDescription>60 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-573-17) </PackageDescription>
<NDC11Code>69452-0573-17</NDC11Code>
<ProductNDC>69452-573</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dextromethorphan Hbr</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>BIONPHARMA INC.</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69452-143-20</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-20) </PackageDescription>
<NDC11Code>69452-0143-20</NDC11Code>
<ProductNDC>69452-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081297</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BENZONATATE is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>69452-143-30</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (69452-143-30) </PackageDescription>
<NDC11Code>69452-0143-30</NDC11Code>
<ProductNDC>69452-143</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081297</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BENZONATATE is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>69452-144-20</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-20) </PackageDescription>
<NDC11Code>69452-0144-20</NDC11Code>
<ProductNDC>69452-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081297</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BENZONATATE is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>69452-144-30</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-30) </PackageDescription>
<NDC11Code>69452-0144-30</NDC11Code>
<ProductNDC>69452-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081297</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BENZONATATE is indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p(butylamino) benzoate; with a molecular weight of 603.7. Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg benzonatate USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, glycerin, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>69452-153-20</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-153-20) </PackageDescription>
<NDC11Code>69452-0153-20</NDC11Code>
<ProductNDC>69452-153</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090802</ApplicationNumber>
<LabelerName>BionPharma Inc.,</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules, USP are available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide . The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69452-154-20</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-154-20) </PackageDescription>
<NDC11Code>69452-0154-20</NDC11Code>
<ProductNDC>69452-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090802</ApplicationNumber>
<LabelerName>BionPharma Inc.,</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules, USP are available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide . The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69452-155-20</NDCCode>
<PackageDescription>100 CAPSULE, GELATIN COATED in 1 BOTTLE (69452-155-20) </PackageDescription>
<NDC11Code>69452-0155-20</NDC11Code>
<ProductNDC>69452-155</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090802</ApplicationNumber>
<LabelerName>BionPharma Inc.,</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in Tacrolimus Capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as [3S [3R*[E(1S*, 3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]] 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone, monohydrate. The chemical structure of tacrolimus USP is. Tacrolimus USP has an empirical formula of C 44H 69NO 12H 2O and a formula weight of 822.03. Tacrolimus appears as white to off white powder. It is soluble in acetone, chloroform, ethyl acetate and insoluble in water. Tacrolimus Capsules, USP are available for oral administration as capsules (tacrolimus capsules) containing the equivalent of 0.5 mg, 1 mg or 5 mg of tacrolimus USP. Inactive ingredients include croscarmellose sodium NF, hypromellose USP, lactose anhydrous USNF, and magnesium stearate USNF. The 0.5 mg capsule shell contains ferric oxide, gelatin and titanium dioxide. The 1 mg capsule shell contains gelatin and titanium dioxide . The 5 mg capsule shell contains ferric oxide, gelatin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69452-156-73</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (69452-156-73) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (69452-156-74) </PackageDescription>
<NDC11Code>69452-0156-73</NDC11Code>
<ProductNDC>69452-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizatriptan Benzoate</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204722</ApplicationNumber>
<LabelerName>Bionpharma Inc.,</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rizatriptan Benzoate Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use: 1 Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, USP, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, USP are administered to treat any subsequent attacks., 2 Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)] . , 3 Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks., 4 Safety and effectiveness of Rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Rizatriptan Benzoate Orally Disintegrating Tablet contains rizatriptan benzoate, a selective 5-hydroxytryptamine (5- 1B/1D HT ) receptor agonist. Rizatriptan benzoate is described 1B/1D chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is. Its empirical formula is C 15H 19N 5C 7H 6O 2, representing a molecular weight of the free base of 269.4. Rizatriptan Benzoate is a white to off-white crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. Rizatriptan Benzoate Orally Disintegrating Tablets are available for oral administration in strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). Each compressed tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, colloidal silicon dioxide, xylitol, anhydrous dibasic calcium phosphate, crospovidone, mannitol, sodium stearyl fumarate, aspartame, isopropyl alcohol and menthol.</Description>
</NDC>
</NDCList>