{
"NDC": [
{
"NDCCode": "83324-317-72",
"PackageDescription": "72 TABLET, CHEWABLE in 1 BOTTLE (83324-317-72) ",
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"ProductNDC": "83324-317",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "Ultra Strength",
"NonProprietaryName": "Antacid Tablets (calcium Carbonate)",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "QUALITY CHOICE (Chain drug Marketing Assoiciation)",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
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"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20241111",
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"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "51862-317-78",
"PackageDescription": "5 POUCH in 1 CARTON (51862-317-78) > 1 PATCH in 1 POUCH (51862-317-52) > 72 h in 1 PATCH",
"NDC11Code": "51862-0317-78",
"ProductNDC": "51862-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
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"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Mayne Pharma",
"SubstanceName": "FENTANYL",
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"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
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"LastUpdate": "2020-05-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "65734-317-72",
"PackageDescription": "72 APPLICATOR in 1 PACKAGE (65734-317-72) > .15 mL in 1 APPLICATOR (65734-317-00)",
"NDC11Code": "65734-0317-72",
"ProductNDC": "65734-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iodine",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Swabplus Inc.",
"SubstanceName": "POVIDONE-IODINE",
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"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Hold the swab vertically, with the color ring tip upwards. Hold in the center of the tube with one hand at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use."
},
{
"NDCCode": "83324-126-72",
"PackageDescription": "72 TABLET, CHEWABLE in 1 BOTTLE (83324-126-72) ",
"NDC11Code": "83324-0126-72",
"ProductNDC": "83324-126",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Qch Ultra Strength Antacid Assorted Berry 171ab",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20240709",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Chain Drug Marketing Association Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240709",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "83324-127-72",
"PackageDescription": "72 TABLET, CHEWABLE in 1 BOTTLE (83324-127-72) ",
"NDC11Code": "83324-0127-72",
"ProductNDC": "83324-127",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Qch Ultra Strength Antacid 171af",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20240803",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Chain Drug Marketing Association Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240803",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 acid indigestion, 2 heartburn."
},
{
"NDCCode": "83324-314-72",
"PackageDescription": "72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (83324-314-72) ",
"NDC11Code": "83324-0314-72",
"ProductNDC": "83324-314",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice",
"ProprietaryNameSuffix": "Ultra Strength",
"NonProprietaryName": "Antacid Tablet (calcium Carbonate)",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "QUALITY CHOICE (Chain drug Marketing Assoiciation)",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241111",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "83324-131-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (83324-131-90) ",
"NDC11Code": "83324-0131-90",
"ProductNDC": "83324-131",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fiber Caplets 147",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240827",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Chain Drug Marketing Association Inc.",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2024-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240827",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "83324-197-01",
"PackageDescription": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (83324-197-01) ",
"NDC11Code": "83324-0197-01",
"ProductNDC": "83324-197",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20251202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Chain Drug Marketing Association",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251202",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 12 to 72 hours."
},
{
"NDCCode": "83324-197-25",
"PackageDescription": "250 CAPSULE, LIQUID FILLED in 1 BOTTLE (83324-197-25) ",
"NDC11Code": "83324-0197-25",
"ProductNDC": "83324-197",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice Stool Softener",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20251202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "Chain Drug Marketing Association",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251202",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation (irregularity). generally produces a bowel movement in 12 to 72 hours."
},
{
"NDCCode": "83324-228-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (83324-228-01) ",
"NDC11Code": "83324-0228-01",
"ProductNDC": "83324-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice",
"ProprietaryNameSuffix": "Fiber Therapy",
"NonProprietaryName": "Methylcellulose",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240920",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CHAIN DRUG MARKETING ASSOCIATION",
"SubstanceName": "METHYLCELLULOSE (4000 MPA.S)",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240920",
"SamplePackage": "N",
"IndicationAndUsage": "relieves constipation (irregularity). generally produces a bowel movement in 12 -72 hours."
},
{
"NDCCode": "83324-276-14",
"PackageDescription": "140 TABLET, FILM COATED in 1 BOTTLE (83324-276-14) ",
"NDC11Code": "83324-0276-14",
"ProductNDC": "83324-276",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice",
"ProprietaryNameSuffix": "Fiber Caplets",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250602",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation to help restore and maintain regularity. this product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "83324-276-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (83324-276-90) ",
"NDC11Code": "83324-0276-90",
"ProductNDC": "83324-276",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice",
"ProprietaryNameSuffix": "Fiber Caplets",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250602",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250602",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation to help restore and maintain regularity. this product generally produces bowel movement in 12 to 72 hours."
},
{
"NDCCode": "0517-1820-01",
"PackageDescription": "1 VIAL in 1 CARTON (0517-1820-01) > 18 mL in 1 VIAL",
"NDC11Code": "00517-1820-01",
"ProductNDC": "0517-1820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide Sodium",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202561",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2020-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorothiazide sodium for injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing. Chlorothiazide Sodium equivalent to Chlorothiazide……………500 mg. Inactive ingredients:Mannitol………………………………………...…………………..250 mgSodium Hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "17478-419-40",
"PackageDescription": "1 VIAL in 1 CARTON (17478-419-40) > 1 INJECTION in 1 VIAL",
"NDC11Code": "17478-0419-40",
"ProductNDC": "17478-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide Sodium",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120813",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA011145",
"LabelerName": "Akorn",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120813",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorothiazide Sodium for Injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing:. Chlorothiazide sodium equivalent to chlorothiazide ........................................................................ 500 mg. Inactive ingredients: Mannitol.......................................................................................................................................... 250 mg. Sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "25021-305-20",
"PackageDescription": "1 VIAL in 1 CARTON (25021-305-20) / 18 mL in 1 VIAL",
"NDC11Code": "25021-0305-20",
"ProductNDC": "25021-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide Sodium",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202462",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151012",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "25021-305-66",
"PackageDescription": "1 VIAL in 1 CARTON (25021-305-66) / 18 mL in 1 VIAL",
"NDC11Code": "25021-0305-66",
"ProductNDC": "25021-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide Sodium",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202462",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191215",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "33342-317-10",
"PackageDescription": "90 TABLET in 1 BOTTLE (33342-317-10) ",
"NDC11Code": "33342-0317-10",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (33342-317-11) ",
"NDC11Code": "33342-0317-11",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260521",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-317-12) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "33342-0317-12",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-15",
"PackageDescription": "500 TABLET in 1 BOTTLE (33342-317-15) ",
"NDC11Code": "33342-0317-15",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240603",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "33342-317-44",
"PackageDescription": "1000 TABLET in 1 BOTTLE (33342-317-44) ",
"NDC11Code": "33342-0317-44",
"ProductNDC": "33342-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atorvastatin Calcium",
"NonProprietaryName": "Atorvastatin Calcium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208480",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260527",
"SamplePackage": "N",
"IndicationAndUsage": "Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.",
"Description": "Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol."
},
{
"NDCCode": "47335-330-40",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (47335-330-40) / 18 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "47335-0330-40",
"ProductNDC": "47335-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide Sodium",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091546",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160825",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Use in PregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.",
"Description": "Chlorothiazide sodium is a diuretic and antihypertensive. It is 6-chloro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its molecular formula is C7H5ClN3NaO4S2 and its structural formula is. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing:Chlorothiazide sodium equivalent to chlorothiazide USP........................................ 500 mgInactive ingredients:Mannitol .................................................................................................................. 250 mgSodium hydroxide to adjust pH.Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2 H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H6ClN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is insoluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "55150-317-10",
"PackageDescription": "10 AMPULE in 1 CARTON (55150-317-10) / 5 mL in 1 AMPULE (55150-317-01) ",
"NDC11Code": "55150-0317-10",
"ProductNDC": "55150-317",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoproterenol Hydrochloride",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20210209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211864",
"LabelerName": "Eugia US LLC",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210209",
"SamplePackage": "N",
"IndicationAndUsage": "Isoproterenol hydrochloride injection is indicated.",
"Description": "Isoproterenol hydrochloride injection, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. Isoproterenol hydrochloride is white to practically white, crystalline powder and the molecular formula is C11H17NO3 ·HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic clear, colorless or practically colorless liquid free from visible particles and can be administered by the intravenous route."
},
{
"NDCCode": "61649-317-01",
"PackageDescription": "100 mL in 1 BOTTLE, SPRAY (61649-317-01) ",
"NDC11Code": "61649-0317-01",
"ProductNDC": "61649-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bio Spectra",
"ProprietaryNameSuffix": "Attitude",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BIO SPECTRA",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201115",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "61649-317-02",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (61649-317-02) ",
"NDC11Code": "61649-0317-02",
"ProductNDC": "61649-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bio Spectra",
"ProprietaryNameSuffix": "Attitude",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201115",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BIO SPECTRA",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201115",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "63323-658-20",
"PackageDescription": "1 VIAL in 1 BOX (63323-658-20) / 18 mL in 1 VIAL",
"NDC11Code": "63323-0658-20",
"ProductNDC": "63323-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090896",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091021",
"SamplePackage": "N",
"Description": "Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is. C7H5ClN3NaO4S2 M.W. 317.71. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. C7H6ClN3O4S2 M.W. 295.72. It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "63323-658-27",
"PackageDescription": "1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL",
"NDC11Code": "63323-0658-27",
"ProductNDC": "63323-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090896",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2023-06-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20091021",
"SamplePackage": "N",
"Description": "Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is. C7H5ClN3NaO4S2 M.W. 317.71. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. C7H6ClN3O4S2 M.W. 295.72. It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "63323-658-94",
"PackageDescription": "1 VIAL in 1 BOX (63323-658-94) / 18 mL in 1 VIAL",
"NDC11Code": "63323-0658-94",
"ProductNDC": "63323-658",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20091021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090896",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20091021",
"SamplePackage": "N",
"Description": "Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is. C7H5ClN3NaO4S2 M.W. 317.71. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. C7H6ClN3O4S2 M.W. 295.72. It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "68083-614-01",
"PackageDescription": "1 VIAL in 1 CARTON (68083-614-01) / 18 mL in 1 VIAL",
"NDC11Code": "68083-0614-01",
"ProductNDC": "68083-614",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorothiazide Sodium",
"NonProprietaryName": "Chlorothiazide Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218630",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "CHLOROTHIAZIDE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/18mL",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2024-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241003",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.",
"Description": "Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide………….500 mg Inactive ingredients: Mannitol……………………………….250 mg Sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7."
},
{
"NDCCode": "69842-317-30",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69842-317-30) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "69842-0317-30",
"ProductNDC": "69842-317",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stool Softener Laxative",
"NonProprietaryName": "Docusate Sodium",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20210730",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M007",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "DOCUSATE SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210730",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional constipation (irregularity) . this product generally produces bowel movement in 12 to 72 hours."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83324-317-72</NDCCode>
<PackageDescription>72 TABLET, CHEWABLE in 1 BOTTLE (83324-317-72) </PackageDescription>
<NDC11Code>83324-0317-72</NDC11Code>
<ProductNDC>83324-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51862-317-78</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (51862-317-78) > 1 PATCH in 1 POUCH (51862-317-52) > 72 h in 1 PATCH</PackageDescription>
<NDC11Code>51862-0317-78</NDC11Code>
<ProductNDC>51862-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20171002</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077062</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-05-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65734-317-72</NDCCode>
<PackageDescription>72 APPLICATOR in 1 PACKAGE (65734-317-72) > .15 mL in 1 APPLICATOR (65734-317-00)</PackageDescription>
<NDC11Code>65734-0317-72</NDC11Code>
<ProductNDC>65734-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iodine</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Swabplus Inc.</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hold the swab vertically, with the color ring tip upwards. Hold in the center of the tube with one hand at the color ring with the other. Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip. Apply the product to the affected area. Discard swab after use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-126-72</NDCCode>
<PackageDescription>72 TABLET, CHEWABLE in 1 BOTTLE (83324-126-72) </PackageDescription>
<NDC11Code>83324-0126-72</NDC11Code>
<ProductNDC>83324-126</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Qch Ultra Strength Antacid Assorted Berry 171ab</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-127-72</NDCCode>
<PackageDescription>72 TABLET, CHEWABLE in 1 BOTTLE (83324-127-72) </PackageDescription>
<NDC11Code>83324-0127-72</NDC11Code>
<ProductNDC>83324-127</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Qch Ultra Strength Antacid 171af</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 acid indigestion, 2 heartburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-314-72</NDCCode>
<PackageDescription>72 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (83324-314-72) </PackageDescription>
<NDC11Code>83324-0314-72</NDC11Code>
<ProductNDC>83324-314</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice</ProprietaryName>
<ProprietaryNameSuffix>Ultra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Antacid Tablet (calcium Carbonate)</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain drug Marketing Assoiciation)</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 acid indigestion, 3 sour stomach, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-131-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (83324-131-90) </PackageDescription>
<NDC11Code>83324-0131-90</NDC11Code>
<ProductNDC>83324-131</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fiber Caplets 147</ProprietaryName>
<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240827</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association Inc.</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-197-01</NDCCode>
<PackageDescription>100 CAPSULE, LIQUID FILLED in 1 BOTTLE (83324-197-01) </PackageDescription>
<NDC11Code>83324-0197-01</NDC11Code>
<ProductNDC>83324-197</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-197-25</NDCCode>
<PackageDescription>250 CAPSULE, LIQUID FILLED in 1 BOTTLE (83324-197-25) </PackageDescription>
<NDC11Code>83324-0197-25</NDC11Code>
<ProductNDC>83324-197</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice Stool Softener</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation (irregularity). generally produces a bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-228-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (83324-228-01) </PackageDescription>
<NDC11Code>83324-0228-01</NDC11Code>
<ProductNDC>83324-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice</ProprietaryName>
<ProprietaryNameSuffix>Fiber Therapy</ProprietaryNameSuffix>
<NonProprietaryName>Methylcellulose</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240920</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>CHAIN DRUG MARKETING ASSOCIATION</LabelerName>
<SubstanceName>METHYLCELLULOSE (4000 MPA.S)</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves constipation (irregularity). generally produces a bowel movement in 12 -72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-276-14</NDCCode>
<PackageDescription>140 TABLET, FILM COATED in 1 BOTTLE (83324-276-14) </PackageDescription>
<NDC11Code>83324-0276-14</NDC11Code>
<ProductNDC>83324-276</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice</ProprietaryName>
<ProprietaryNameSuffix>Fiber Caplets</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation to help restore and maintain regularity. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-276-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (83324-276-90) </PackageDescription>
<NDC11Code>83324-0276-90</NDC11Code>
<ProductNDC>83324-276</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice</ProprietaryName>
<ProprietaryNameSuffix>Fiber Caplets</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M007</ApplicationNumber>
<LabelerName>QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation to help restore and maintain regularity. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0517-1820-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0517-1820-01) > 18 mL in 1 VIAL</PackageDescription>
<NDC11Code>00517-1820-01</NDC11Code>
<ProductNDC>0517-1820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorothiazide Sodium</ProprietaryName>
<NonProprietaryName>Chlorothiazide Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202561</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>CHLOROTHIAZIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-06-10</LastUpdate>
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<IndicationAndUsage>Chlorothiazide sodium for injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing. Chlorothiazide Sodium equivalent to Chlorothiazide……………500 mg. Inactive ingredients:Mannitol………………………………………...…………………..250 mgSodium Hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<LabelerName>Akorn</LabelerName>
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<LastUpdate>2024-01-02</LastUpdate>
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<IndicationAndUsage>Chlorothiazide Sodium for Injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing:. Chlorothiazide sodium equivalent to chlorothiazide ........................................................................ 500 mg. Inactive ingredients: Mannitol.......................................................................................................................................... 250 mg. Sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
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<RouteName>INTRAVENOUS</RouteName>
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<ApplicationNumber>ANDA202462</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CHLOROTHIAZIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
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<IndicationAndUsage>Chlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
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<PackageDescription>1 VIAL in 1 CARTON (25021-305-66) / 18 mL in 1 VIAL</PackageDescription>
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<ProductNDC>25021-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorothiazide Sodium</ProprietaryName>
<NonProprietaryName>Chlorothiazide Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202462</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CHLOROTHIAZIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-08</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorothiazide Sodium for Injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide Sodium for Injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:. Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
</NDC>
<NDC>
<NDCCode>33342-317-10</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (33342-317-10) </PackageDescription>
<NDC11Code>33342-0317-10</NDC11Code>
<ProductNDC>33342-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
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<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
<NDC>
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<PackageDescription>100 TABLET in 1 BOTTLE (33342-317-11) </PackageDescription>
<NDC11Code>33342-0317-11</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240603</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208480</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
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<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
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<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
</NDC>
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<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Atorvastatin calcium tablets is indicated: To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia. o Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Atorvastatin, USP is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium, USP is [R-R*, R*)]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The empirical formula of atorvastatin calcium, USP is (C33H34FN2O5)2Ca3H2O and its molecular weight is 1209.42. Its structural formula is:. Atorvastatin calcium, USP is a white to off-white crystalline powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium, USP is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USPfor oral administration contain 10, 20, 40, or 80 mg (equivalent to 10.34 mg, 20.68 mg, 41.36 mg, or 82.72 mg atorvastatin calcium anhydrous) atorvastatin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, hydroxypropyl cellulose, polysorbate 80, magnesium stearate, hypromellose, talc, titanium dioxide, polyethylene glycol.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorothiazide Sodium</ProprietaryName>
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<StartMarketingDate>20160825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091546</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>CHLOROTHIAZIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Use in PregnancyRoutine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
<Description>Chlorothiazide sodium is a diuretic and antihypertensive. It is 6-chloro-2 H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its molecular formula is C7H5ClN3NaO4S2 and its structural formula is. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing:Chlorothiazide sodium equivalent to chlorothiazide USP........................................ 500 mgInactive ingredients:Mannitol .................................................................................................................. 250 mgSodium hydroxide to adjust pH.Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2 H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C7H6ClN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is insoluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
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<PackageDescription>10 AMPULE in 1 CARTON (55150-317-10) / 5 mL in 1 AMPULE (55150-317-01) </PackageDescription>
<NDC11Code>55150-0317-10</NDC11Code>
<ProductNDC>55150-317</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoproterenol Hydrochloride</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20210209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211864</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>ISOPROTERENOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoproterenol hydrochloride injection is indicated.</IndicationAndUsage>
<Description>Isoproterenol hydrochloride injection, USP is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. Isoproterenol hydrochloride is white to practically white, crystalline powder and the molecular formula is C11H17NO3 ·HCl. It has a molecular weight of 247.72 and the following structural formula. Isoproterenol hydrochloride, USP is a racemic compound. The pH is adjusted between 2.5 and 4.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic clear, colorless or practically colorless liquid free from visible particles and can be administered by the intravenous route.</Description>
</NDC>
<NDC>
<NDCCode>61649-317-01</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, SPRAY (61649-317-01) </PackageDescription>
<NDC11Code>61649-0317-01</NDC11Code>
<ProductNDC>61649-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bio Spectra</ProprietaryName>
<ProprietaryNameSuffix>Attitude</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BIO SPECTRA</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-20</LastUpdate>
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<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201115</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>
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<NDCCode>61649-317-02</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (61649-317-02) </PackageDescription>
<NDC11Code>61649-0317-02</NDC11Code>
<ProductNDC>61649-317</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bio Spectra</ProprietaryName>
<ProprietaryNameSuffix>Attitude</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BIO SPECTRA</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201115</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>63323-658-20</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (63323-658-20) / 18 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0658-20</NDC11Code>
<ProductNDC>63323-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorothiazide</ProprietaryName>
<NonProprietaryName>Chlorothiazide Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090896</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CHLOROTHIAZIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is. C7H5ClN3NaO4S2 M.W. 317.71. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. C7H6ClN3O4S2 M.W. 295.72. It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
</NDC>
<NDC>
<NDCCode>63323-658-27</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (63323-658-27) / 18 mL in 1 VIAL</PackageDescription>
<NDC11Code>63323-0658-27</NDC11Code>
<ProductNDC>63323-658</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorothiazide</ProprietaryName>
<NonProprietaryName>Chlorothiazide Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20091021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090896</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>CHLOROTHIAZIDE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is. C7H5ClN3NaO4S2 M.W. 317.71. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. C7H6ClN3O4S2 M.W. 295.72. It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
</NDC>
<NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090896</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
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<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/18mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<Description>Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its structural formula is. C7H5ClN3NaO4S2 M.W. 317.71. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is. C7H6ClN3O4S2 M.W. 295.72. It is a white, or practically white, crystalline powder, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
</NDC>
<NDC>
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<Status>Active</Status>
<LastUpdate>2024-10-10</LastUpdate>
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<IndicationAndUsage>Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.</IndicationAndUsage>
<Description>Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt, and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is. Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide………….500 mg Inactive ingredients: Mannitol……………………………….250 mg Sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is. It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.</Description>
</NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stool Softener Laxative</ProprietaryName>
<NonProprietaryName>Docusate Sodium</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>DOCUSATE SODIUM</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<IndicationAndUsage>for relief of occasional constipation (irregularity) . this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
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