{
"NDC": [
{
"NDCCode": "73856-535-18",
"PackageDescription": "500 mL in 1 BOTTLE (73856-535-18) ",
"NDC11Code": "73856-0535-18",
"ProductNDC": "73856-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Imk Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200420",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Biopontis inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "350",
"StrengthUnit": "mL/500mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitized to help reduce bacteria on the skin."
},
{
"NDCCode": "0116-1022-18",
"PackageDescription": "535 mL in 1 BOTTLE (0116-1022-18) ",
"NDC11Code": "00116-1022-18",
"ProductNDC": "0116-1022",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dyna-hex 2",
"NonProprietaryName": "Chlorhexidine Gluconate 2%",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019422",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2020-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N",
"IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing ."
},
{
"NDCCode": "0116-1060-18",
"PackageDescription": "535 mL in 1 BOTTLE, PLASTIC (0116-1060-18) ",
"NDC11Code": "00116-1060-18",
"ProductNDC": "0116-1060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dyna-hex 4",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019125",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "4",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2023-11-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N",
"IndicationAndUsage": "surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing ."
},
{
"NDCCode": "74588-535-05",
"PackageDescription": "18.927 L in 1 DRUM (74588-535-05) ",
"NDC11Code": "74588-0535-05",
"ProductNDC": "74588-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer B2",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Global Impact Innovation LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "168.11466",
"StrengthUnit": "L/208L",
"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": "0409-4166-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4166-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4166-03",
"ProductNDC": "0409-4166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Rf",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, And Histidine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018429",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ARGININE; HISTIDINE",
"StrengthNumber": "462; 726; 535; 726; 726; 330; 165; 528; 600; 429",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "51316-535-01",
"PackageDescription": "19.8 g in 1 CONTAINER (51316-535-01) ",
"NDC11Code": "51316-0535-01",
"ProductNDC": "51316-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Healing Balm Skin Protectant",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "347",
"LabelerName": "CVS",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects minor: cuts· scrapes· burns. Temporarily protects and helps relieve chapped or cracked skin and lips· helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "54473-218-06",
"PackageDescription": "177 mL in 1 TUBE (54473-218-06) ",
"NDC11Code": "54473-0218-06",
"ProductNDC": "54473-218",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Shades Mineral Plus Sunscreen",
"ProprietaryNameSuffix": "With Zinc Oxide",
"NonProprietaryName": "Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121227",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Melaleuca Inc.",
"SubstanceName": "OCTISALATE; OCTOCRYLENE; ZINC OXIDE",
"StrengthNumber": "9.225; 5.535; 18.45",
"StrengthUnit": "g/177mL; g/177mL; g/177mL",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "59137-535-01",
"PackageDescription": "1 PACKAGE in 1 CARTON (59137-535-01) / .45 mL in 1 PACKAGE (59137-535-00) ",
"NDC11Code": "59137-0535-01",
"ProductNDC": "59137-535",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasuvo",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20140710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205776",
"LabelerName": "Medexus Pharma Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "22.5",
"StrengthUnit": "mg/.45mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140710",
"SamplePackage": "N",
"IndicationAndUsage": "Rasuvo is a folate analog metabolic inhibitor indicated for the: 1 Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1), 2 Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2).",
"Description": "Rasuvo contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C20H22N8O5 M.W.= 454.45. Rasuvo contains methotrexate in a sterile, preservative-free, non-pyrogenic solution for a single subcutaneous injection. Rasuvo is an isotonic, clear, yellow to brown solution. Rasuvo contains the following inactive ingredients: sodium chloride 0.4% w/v; water for injections, sodium hydroxide and, if necessary, hydrochloric acid are added to adjust the pH to approximately 8.5."
},
{
"NDCCode": "59137-535-04",
"PackageDescription": "4 PACKAGE in 1 CARTON (59137-535-04) / .45 mL in 1 PACKAGE (59137-535-00) ",
"NDC11Code": "59137-0535-04",
"ProductNDC": "59137-535",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rasuvo",
"NonProprietaryName": "Methotrexate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20140710",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205776",
"LabelerName": "Medexus Pharma Inc.",
"SubstanceName": "METHOTREXATE SODIUM",
"StrengthNumber": "22.5",
"StrengthUnit": "mg/.45mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140710",
"SamplePackage": "N",
"IndicationAndUsage": "Rasuvo is a folate analog metabolic inhibitor indicated for the: 1 Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1), 2 Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2).",
"Description": "Rasuvo contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C20H22N8O5 M.W.= 454.45. Rasuvo contains methotrexate in a sterile, preservative-free, non-pyrogenic solution for a single subcutaneous injection. Rasuvo is an isotonic, clear, yellow to brown solution. Rasuvo contains the following inactive ingredients: sodium chloride 0.4% w/v; water for injections, sodium hydroxide and, if necessary, hydrochloric acid are added to adjust the pH to approximately 8.5."
},
{
"NDCCode": "76184-0101-8",
"PackageDescription": "535 mL in 1 BOTTLE (76184-0101-8)",
"NDC11Code": "76184-0101-08",
"ProductNDC": "76184-0101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dermasil Dryskin",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170830",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Fantasia Beauty LLC",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": ".01",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-11-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "73856-545-11",
"PackageDescription": "50 mL in 1 BOTTLE (73856-545-11) ",
"NDC11Code": "73856-0545-11",
"ProductNDC": "73856-545",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Imk Hand Sanitizer",
"NonProprietaryName": "Ethyl Alchocol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200522",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Biopontis inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "35",
"StrengthUnit": "mL/50mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200522",
"SamplePackage": "N",
"IndicationAndUsage": "Use. Hand sanitized to help reduce bacteria on the skin."
},
{
"NDCCode": "0091-3707-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0091-3707-01)",
"NDC11Code": "00091-3707-01",
"ProductNDC": "0091-3707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Univasc",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19950715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020312",
"LabelerName": "UCB, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).",
"Description": "univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide."
},
{
"NDCCode": "0091-3707-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0091-3707-09)",
"NDC11Code": "00091-3707-09",
"ProductNDC": "0091-3707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Univasc",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19950715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020312",
"LabelerName": "UCB, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).",
"Description": "univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide."
},
{
"NDCCode": "0093-0017-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0093-0017-01) ",
"NDC11Code": "00093-0017-01",
"ProductNDC": "0093-0017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moexipril Hydrochloride",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076204",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030508",
"SamplePackage": "N",
"IndicationAndUsage": "Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,Angioedema).",
"Description": "Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is. C27H34N2O7HCl M.W. 535.04. Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2."
},
{
"NDCCode": "0093-5150-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0093-5150-01) ",
"NDC11Code": "00093-5150-01",
"ProductNDC": "0093-5150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moexipril Hydrochloride",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076204",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030508",
"SamplePackage": "N",
"IndicationAndUsage": "Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,Angioedema).",
"Description": "Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is. C27H34N2O7HCl M.W. 535.04. Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2."
},
{
"NDCCode": "0597-9257-59",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-59) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "00597-9257-59",
"ProductNDC": "0597-9257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hernexeos",
"NonProprietaryName": "Zongertinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219042",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "ZONGERTINIB",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], HER2/Neu/cerbB2 Antagonists [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260106",
"SamplePackage": "N",
"IndicationAndUsage": "HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
"Description": "HERNEXEOS tablets for oral administration contain zongertinib, a kinase inhibitor. The chemical name of zongertinib is 2-Propenamide, N-[1-[8-[[3-methyl-4-[(1-methyl-1H-benzimidazol-5-yl)oxy]phenyl] amino]pyrimido[5,4-d]pyrimidin-2-yl]-4-piperidinyl]-. Its molecular formula is C29H29N9O2 and the molecular weight is 535.6. The structural formula is. Zongertinib is a yellow to dark yellow or orange solid. Zongertinib is slightly soluble at pH 1.2, and practically insoluble at pHs 3.6, 4.5, 5.4 and 6.8. Each film-coated tablet of HERNEXEOS contains 60 mg of zongertinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film-coating contains the following inactive ingredients: ferric oxide (yellow), glycerol mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "0597-9257-86",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-86) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "00597-9257-86",
"ProductNDC": "0597-9257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hernexeos",
"NonProprietaryName": "Zongertinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250808",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA219042",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "ZONGERTINIB",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], HER2/Neu/cerbB2 Antagonists [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250808",
"SamplePackage": "N",
"IndicationAndUsage": "HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.",
"Description": "HERNEXEOS tablets for oral administration contain zongertinib, a kinase inhibitor. The chemical name of zongertinib is 2-Propenamide, N-[1-[8-[[3-methyl-4-[(1-methyl-1H-benzimidazol-5-yl)oxy]phenyl] amino]pyrimido[5,4-d]pyrimidin-2-yl]-4-piperidinyl]-. Its molecular formula is C29H29N9O2 and the molecular weight is 535.6. The structural formula is. Zongertinib is a yellow to dark yellow or orange solid. Zongertinib is slightly soluble at pH 1.2, and practically insoluble at pHs 3.6, 4.5, 5.4 and 6.8. Each film-coated tablet of HERNEXEOS contains 60 mg of zongertinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film-coating contains the following inactive ingredients: ferric oxide (yellow), glycerol mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "0941-0679-05",
"PackageDescription": "2500 mL in 1 BAG (0941-0679-05) ",
"NDC11Code": "00941-0679-05",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0679-06",
"PackageDescription": "2000 mL in 1 BAG (0941-0679-06) ",
"NDC11Code": "00941-0679-06",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0679-45",
"PackageDescription": "1500 mL in 1 BAG (0941-0679-45)",
"NDC11Code": "00941-0679-45",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-47",
"PackageDescription": "2000 mL in 1 BAG (0941-0679-47)",
"NDC11Code": "00941-0679-47",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-48",
"PackageDescription": "2500 mL in 1 BAG (0941-0679-48)",
"NDC11Code": "00941-0679-48",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-51",
"PackageDescription": "1500 mL in 1 BAG (0941-0679-51)",
"NDC11Code": "00941-0679-51",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
"StrengthNumber": "25.7; 7.5; 5.08; 535; 448",
"StrengthUnit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-12-26"
},
{
"NDCCode": "0941-0679-52",
"PackageDescription": "2000 mL in 1 BAG (0941-0679-52) ",
"NDC11Code": "00941-0679-52",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0941-0679-53",
"PackageDescription": "2500 mL in 1 BAG (0941-0679-53) ",
"NDC11Code": "00941-0679-53",
"ProductNDC": "0941-0679",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Extraneal",
"NonProprietaryName": "Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAPERITONEAL",
"StartMarketingDate": "20021220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021321",
"LabelerName": "Vantive US Healthcare LLC",
"SubstanceName": "ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE",
"StrengthNumber": "7.5; 535; 448; 25.7; 5.08",
"StrengthUnit": "g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20021220",
"SamplePackage": "N",
"IndicationAndUsage": "EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].",
"Description": "EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "10056-535-76",
"PackageDescription": "1 BOTTLE in 1 CARTON (10056-535-76) > 120 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "10056-0535-76",
"ProductNDC": "10056-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Formucare Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20060227",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Access Business Group International LLC",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-11-22"
},
{
"NDCCode": "10544-535-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10544-535-30)",
"NDC11Code": "10544-0535-30",
"ProductNDC": "10544-535",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20131003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078596",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Metformin HCl extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride (HCl) extended-release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin HCl, USP ( N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin HCl, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin HCl, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl, USP is 6.68. Metformin HCl extended-release tablets, USP contain 500 mg or 750 mg of metformin HCl, USP as the active ingredient. Metformin HCl extended-release tablets, USP 500 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Metformin HCl extended-release tablets, USP 750 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose and magnesium stearate. Dissolution Method: Test 10. System Components and Performance - Metformin HCl extended-release tablets, USP comprises a dual hydrophilic polymer matrix system. Metformin HCl, USP is combined with a drug release controlling polymer to form an \"inner\" phase, which is then incorporated as discrete particles into an \"external\" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass."
},
{
"NDCCode": "10812-535-01",
"PackageDescription": "88 mL in 1 TUBE (10812-535-01) ",
"NDC11Code": "10812-0535-01",
"ProductNDC": "10812-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Ultra Sheer Dry Touch",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050901",
"EndMarketingDate": "20220509",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 28; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050901",
"EndMarketingDatePackage": "20211208",
"SamplePackage": "N"
},
{
"NDCCode": "10812-535-02",
"PackageDescription": "12 TUBE in 1 TRAY (10812-535-02) > 14 mL in 1 TUBE",
"NDC11Code": "10812-0535-02",
"ProductNDC": "10812-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Ultra Sheer Dry Touch",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121011",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 28; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2016-02-05"
},
{
"NDCCode": "10812-535-03",
"PackageDescription": "2 TUBE in 1 PACKAGE (10812-535-03) > 88 mL in 1 TUBE",
"NDC11Code": "10812-0535-03",
"ProductNDC": "10812-535",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Ultra Sheer Dry Touch",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf45",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 100; 50; 28; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20050901",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>73856-535-18</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (73856-535-18) </PackageDescription>
<NDC11Code>73856-0535-18</NDC11Code>
<ProductNDC>73856-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Imk Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200420</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Biopontis inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mL/500mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitized to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0116-1022-18</NDCCode>
<PackageDescription>535 mL in 1 BOTTLE (0116-1022-18) </PackageDescription>
<NDC11Code>00116-1022-18</NDC11Code>
<ProductNDC>0116-1022</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dyna-hex 2</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate 2%</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019422</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0116-1060-18</NDCCode>
<PackageDescription>535 mL in 1 BOTTLE, PLASTIC (0116-1060-18) </PackageDescription>
<NDC11Code>00116-1060-18</NDC11Code>
<ProductNDC>0116-1060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dyna-hex 4</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019125</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: helps reduce bacteria that potentially can cause disease . skin wound and general skin cleansing .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74588-535-05</NDCCode>
<PackageDescription>18.927 L in 1 DRUM (74588-535-05) </PackageDescription>
<NDC11Code>74588-0535-05</NDC11Code>
<ProductNDC>74588-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer B2</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Global Impact Innovation LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>168.11466</StrengthNumber>
<StrengthUnit>L/208L</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>0409-4166-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4166-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4166-03</NDC11Code>
<ProductNDC>0409-4166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Rf</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, And Histidine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018429</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ARGININE; HISTIDINE</SubstanceName>
<StrengthNumber>462; 726; 535; 726; 726; 330; 165; 528; 600; 429</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51316-535-01</NDCCode>
<PackageDescription>19.8 g in 1 CONTAINER (51316-535-01) </PackageDescription>
<NDC11Code>51316-0535-01</NDC11Code>
<ProductNDC>51316-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Healing Balm Skin Protectant</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>347</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects minor: cuts· scrapes· burns. Temporarily protects and helps relieve chapped or cracked skin and lips· helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54473-218-06</NDCCode>
<PackageDescription>177 mL in 1 TUBE (54473-218-06) </PackageDescription>
<NDC11Code>54473-0218-06</NDC11Code>
<ProductNDC>54473-218</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Shades Mineral Plus Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>With Zinc Oxide</ProprietaryNameSuffix>
<NonProprietaryName>Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121227</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Melaleuca Inc.</LabelerName>
<SubstanceName>OCTISALATE; OCTOCRYLENE; ZINC OXIDE</SubstanceName>
<StrengthNumber>9.225; 5.535; 18.45</StrengthNumber>
<StrengthUnit>g/177mL; g/177mL; g/177mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps prevent sunburn. ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59137-535-01</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (59137-535-01) / .45 mL in 1 PACKAGE (59137-535-00) </PackageDescription>
<NDC11Code>59137-0535-01</NDC11Code>
<ProductNDC>59137-535</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasuvo</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205776</ApplicationNumber>
<LabelerName>Medexus Pharma Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>mg/.45mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rasuvo is a folate analog metabolic inhibitor indicated for the: 1 Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1), 2 Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2).</IndicationAndUsage>
<Description>Rasuvo contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C20H22N8O5 M.W.= 454.45. Rasuvo contains methotrexate in a sterile, preservative-free, non-pyrogenic solution for a single subcutaneous injection. Rasuvo is an isotonic, clear, yellow to brown solution. Rasuvo contains the following inactive ingredients: sodium chloride 0.4% w/v; water for injections, sodium hydroxide and, if necessary, hydrochloric acid are added to adjust the pH to approximately 8.5.</Description>
</NDC>
<NDC>
<NDCCode>59137-535-04</NDCCode>
<PackageDescription>4 PACKAGE in 1 CARTON (59137-535-04) / .45 mL in 1 PACKAGE (59137-535-00) </PackageDescription>
<NDC11Code>59137-0535-04</NDC11Code>
<ProductNDC>59137-535</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rasuvo</ProprietaryName>
<NonProprietaryName>Methotrexate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140710</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205776</ApplicationNumber>
<LabelerName>Medexus Pharma Inc.</LabelerName>
<SubstanceName>METHOTREXATE SODIUM</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>mg/.45mL</StrengthUnit>
<Pharm_Classes>Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rasuvo is a folate analog metabolic inhibitor indicated for the: 1 Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy (1.1), 2 Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (1.2).</IndicationAndUsage>
<Description>Rasuvo contains methotrexate, a folate analog metabolic inhibitor. Chemically, methotrexate is [N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]-Lglutamic acid. The structural formula is. C20H22N8O5 M.W.= 454.45. Rasuvo contains methotrexate in a sterile, preservative-free, non-pyrogenic solution for a single subcutaneous injection. Rasuvo is an isotonic, clear, yellow to brown solution. Rasuvo contains the following inactive ingredients: sodium chloride 0.4% w/v; water for injections, sodium hydroxide and, if necessary, hydrochloric acid are added to adjust the pH to approximately 8.5.</Description>
</NDC>
<NDC>
<NDCCode>76184-0101-8</NDCCode>
<PackageDescription>535 mL in 1 BOTTLE (76184-0101-8)</PackageDescription>
<NDC11Code>76184-0101-08</NDC11Code>
<ProductNDC>76184-0101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dermasil Dryskin</ProprietaryName>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Fantasia Beauty LLC</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>.01</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>73856-545-11</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (73856-545-11) </PackageDescription>
<NDC11Code>73856-0545-11</NDC11Code>
<ProductNDC>73856-545</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Imk Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alchocol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Biopontis inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mL/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. Hand sanitized to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0091-3707-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0091-3707-01)</PackageDescription>
<NDC11Code>00091-3707-01</NDC11Code>
<ProductNDC>0091-3707</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Univasc</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020312</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).</IndicationAndUsage>
<Description>univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>0091-3707-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0091-3707-09)</PackageDescription>
<NDC11Code>00091-3707-09</NDC11Code>
<ProductNDC>0091-3707</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Univasc</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020312</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).</IndicationAndUsage>
<Description>univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>0093-0017-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0093-0017-01) </PackageDescription>
<NDC11Code>00093-0017-01</NDC11Code>
<ProductNDC>0093-0017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moexipril Hydrochloride</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076204</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,Angioedema).</IndicationAndUsage>
<Description>Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is. C27H34N2O7HCl M.W. 535.04. Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0093-5150-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0093-5150-01) </PackageDescription>
<NDC11Code>00093-5150-01</NDC11Code>
<ProductNDC>0093-5150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moexipril Hydrochloride</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076204</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS,Angioedema).</IndicationAndUsage>
<Description>Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is. C27H34N2O7HCl M.W. 535.04. Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0597-9257-59</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-59) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00597-9257-59</NDC11Code>
<ProductNDC>0597-9257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hernexeos</ProprietaryName>
<NonProprietaryName>Zongertinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219042</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZONGERTINIB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], HER2/Neu/cerbB2 Antagonists [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
<Description>HERNEXEOS tablets for oral administration contain zongertinib, a kinase inhibitor. The chemical name of zongertinib is 2-Propenamide, N-[1-[8-[[3-methyl-4-[(1-methyl-1H-benzimidazol-5-yl)oxy]phenyl] amino]pyrimido[5,4-d]pyrimidin-2-yl]-4-piperidinyl]-. Its molecular formula is C29H29N9O2 and the molecular weight is 535.6. The structural formula is. Zongertinib is a yellow to dark yellow or orange solid. Zongertinib is slightly soluble at pH 1.2, and practically insoluble at pHs 3.6, 4.5, 5.4 and 6.8. Each film-coated tablet of HERNEXEOS contains 60 mg of zongertinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film-coating contains the following inactive ingredients: ferric oxide (yellow), glycerol mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0597-9257-86</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-86) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00597-9257-86</NDC11Code>
<ProductNDC>0597-9257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hernexeos</ProprietaryName>
<NonProprietaryName>Zongertinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250808</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA219042</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZONGERTINIB</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], HER2/Neu/cerbB2 Antagonists [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.</IndicationAndUsage>
<Description>HERNEXEOS tablets for oral administration contain zongertinib, a kinase inhibitor. The chemical name of zongertinib is 2-Propenamide, N-[1-[8-[[3-methyl-4-[(1-methyl-1H-benzimidazol-5-yl)oxy]phenyl] amino]pyrimido[5,4-d]pyrimidin-2-yl]-4-piperidinyl]-. Its molecular formula is C29H29N9O2 and the molecular weight is 535.6. The structural formula is. Zongertinib is a yellow to dark yellow or orange solid. Zongertinib is slightly soluble at pH 1.2, and practically insoluble at pHs 3.6, 4.5, 5.4 and 6.8. Each film-coated tablet of HERNEXEOS contains 60 mg of zongertinib and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. In addition, the film-coating contains the following inactive ingredients: ferric oxide (yellow), glycerol mono and dicaprylocaprate, polyvinyl alcohol, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0941-0679-05</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0679-05) </PackageDescription>
<NDC11Code>00941-0679-05</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>7.5; 535; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].</IndicationAndUsage>
<Description>EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0941-0679-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0941-0679-06) </PackageDescription>
<NDC11Code>00941-0679-06</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>7.5; 535; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].</IndicationAndUsage>
<Description>EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0941-0679-45</NDCCode>
<PackageDescription>1500 mL in 1 BAG (0941-0679-45)</PackageDescription>
<NDC11Code>00941-0679-45</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 7.5; 5.08; 535; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0679-47</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0941-0679-47)</PackageDescription>
<NDC11Code>00941-0679-47</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 7.5; 5.08; 535; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0679-48</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0679-48)</PackageDescription>
<NDC11Code>00941-0679-48</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 7.5; 5.08; 535; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0679-51</NDCCode>
<PackageDescription>1500 mL in 1 BAG (0941-0679-51)</PackageDescription>
<NDC11Code>00941-0679-51</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE</SubstanceName>
<StrengthNumber>25.7; 7.5; 5.08; 535; 448</StrengthNumber>
<StrengthUnit>mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-12-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>0941-0679-52</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0941-0679-52) </PackageDescription>
<NDC11Code>00941-0679-52</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>7.5; 535; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].</IndicationAndUsage>
<Description>EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0941-0679-53</NDCCode>
<PackageDescription>2500 mL in 1 BAG (0941-0679-53) </PackageDescription>
<NDC11Code>00941-0679-53</NDC11Code>
<ProductNDC>0941-0679</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Extraneal</ProprietaryName>
<NonProprietaryName>Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAPERITONEAL</RouteName>
<StartMarketingDate>20021220</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021321</ApplicationNumber>
<LabelerName>Vantive US Healthcare LLC</LabelerName>
<SubstanceName>ICODEXTRIN; SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>7.5; 535; 448; 25.7; 5.08</StrengthNumber>
<StrengthUnit>g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20021220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EXTRANEAL (icodextrin) is indicated for a single daily exchange for the long (8- to 16- hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of kidney failure in patients requiring long-term kidney replacement therapy. EXTRANEAL is also indicated to improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET) [see Clinical Pharmacology (12), Clinical Studies (14)].</IndicationAndUsage>
<Description>EXTRANEAL (icodextrin) Peritoneal Dialysis Solution is a solution intended for intraperitoneal administration that contains the colloid osmotic agent icodextrin. Icodextrin is a cornstarch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds with a weight-average molecular weight between 13,000 and 19,000 Daltons and a number average molecular weight between 5,000 and 6,500 Daltons. The representative structural formula of icodextrin is. Each 100 mL of EXTRANEAL contains. Electrolyte content per liter. Water for Injection, USP qs. HCl/NaOH may have been used to adjust pH. EXTRANEAL contains no bacteriostatic or antimicrobial agents. Calculated osmolarity: 282-286 mOsm/L; pH=5.0-6.0. EXTRANEAL is a sterile, nonpyrogenic, clear solution packaged in AMBU-FLEX II and ULTRABAG containers. The container systems are composed of polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>10056-535-76</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (10056-535-76) > 120 TABLET, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>10056-0535-76</NDC11Code>
<ProductNDC>10056-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Formucare Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060227</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Access Business Group International LLC</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>10544-535-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10544-535-30)</PackageDescription>
<NDC11Code>10544-0535-30</NDC11Code>
<ProductNDC>10544-535</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078596</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Metformin HCl extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride (HCl) extended-release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin HCl, USP ( N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:. Metformin HCl, USP is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. Metformin HCl, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl, USP is 6.68. Metformin HCl extended-release tablets, USP contain 500 mg or 750 mg of metformin HCl, USP as the active ingredient. Metformin HCl extended-release tablets, USP 500 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose, magnesium stearate and microcrystalline cellulose. Metformin HCl extended-release tablets, USP 750 mg contain the inactive ingredients; colloidal silicon dioxide, hypromellose and magnesium stearate. Dissolution Method: Test 10. System Components and Performance - Metformin HCl extended-release tablets, USP comprises a dual hydrophilic polymer matrix system. Metformin HCl, USP is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass.</Description>
</NDC>
<NDC>
<NDCCode>10812-535-01</NDCCode>
<PackageDescription>88 mL in 1 TUBE (10812-535-01) </PackageDescription>
<NDC11Code>10812-0535-01</NDC11Code>
<ProductNDC>10812-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Ultra Sheer Dry Touch</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf45</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<EndMarketingDate>20220509</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 28; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050901</StartMarketingDatePackage>
<EndMarketingDatePackage>20211208</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10812-535-02</NDCCode>
<PackageDescription>12 TUBE in 1 TRAY (10812-535-02) > 14 mL in 1 TUBE</PackageDescription>
<NDC11Code>10812-0535-02</NDC11Code>
<ProductNDC>10812-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Ultra Sheer Dry Touch</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf45</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121011</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 28; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-02-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>10812-535-03</NDCCode>
<PackageDescription>2 TUBE in 1 PACKAGE (10812-535-03) > 88 mL in 1 TUBE</PackageDescription>
<NDC11Code>10812-0535-03</NDC11Code>
<ProductNDC>10812-535</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Ultra Sheer Dry Touch</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf45</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 100; 50; 28; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>