{
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"PackageDescription": "4 TRAY in 1 CASE (60687-341-64) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) ",
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"PackageNdcExcludeFlag": "N",
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{
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"PackageDescription": "106 g in 1 BOTTLE (64058-341-64)",
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"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Menthol, Unspecified Form And Camphor (synthetic)",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Concept Laboratories, Inc.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; CAMPHOR (SYNTHETIC)",
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"Status": "Deprecated",
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"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple backache , 2 arthritis , 3 strains , 4 sprains ."
},
{
"NDCCode": "60687-341-07",
"PackageDescription": "8 TRAY in 1 CASE (60687-341-07) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
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"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
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"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N"
},
{
"NDCCode": "60687-341-14",
"PackageDescription": "4 TRAY in 1 CASE (60687-341-14) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-51) > 30 mL in 1 CUP, UNIT-DOSE (60687-341-45) ",
"NDC11Code": "60687-0341-14",
"ProductNDC": "60687-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180901",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210041",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190115",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "60687-341-58",
"PackageDescription": "3 TRAY in 1 CASE (60687-341-58) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) ",
"NDC11Code": "60687-0341-58",
"ProductNDC": "60687-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180901",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210041",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190115",
"EndMarketingDatePackage": "20230331",
"SamplePackage": "N"
},
{
"NDCCode": "60687-341-71",
"PackageDescription": "5 TRAY in 1 CASE (60687-341-71) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) ",
"NDC11Code": "60687-0341-71",
"ProductNDC": "60687-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180901",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210041",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180901",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "60687-341-72",
"PackageDescription": "5 TRAY in 1 CASE (60687-341-72) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-51) > 30 mL in 1 CUP, UNIT-DOSE (60687-341-45) ",
"NDC11Code": "60687-0341-72",
"ProductNDC": "60687-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20180901",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210041",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180901",
"EndMarketingDatePackage": "20230630",
"SamplePackage": "N"
},
{
"NDCCode": "60687-616-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-616-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-616-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-616-44) ",
"NDC11Code": "60687-0616-64",
"ProductNDC": "60687-616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20211022",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "American Health Packaging",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211022",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1, 1 1-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is."
},
{
"NDCCode": "60687-628-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-628-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) ",
"NDC11Code": "60687-0628-64",
"ProductNDC": "60687-628",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220228",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220311",
"EndMarketingDatePackage": "20261031",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-714-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-714-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-714-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-714-44) ",
"NDC11Code": "60687-0714-64",
"ProductNDC": "60687-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate, 0.12% Oral Rinse",
"NonProprietaryName": "Chlorhexidine Gluconate, 0.12% Oral Rinse",
"DosageFormName": "SOLUTION",
"RouteName": "DENTAL",
"StartMarketingDate": "20230614",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075561",
"LabelerName": "American Health Packaging",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230614",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1, 1'-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate product is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is."
},
{
"NDCCode": "60687-870-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-870-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-870-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-870-44) ",
"NDC11Code": "60687-0870-64",
"ProductNDC": "60687-870",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20250918",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216780",
"LabelerName": "American Health Packaging",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250918",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34."
},
{
"NDCCode": "60687-884-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-884-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-884-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-884-44) ",
"NDC11Code": "60687-0884-64",
"ProductNDC": "60687-884",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride Oral",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20250330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211648",
"LabelerName": "American Health Packaging",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.5",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250421",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.",
"Description": "Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose."
},
{
"NDCCode": "60687-917-64",
"PackageDescription": "4 TRAY in 1 CASE (60687-917-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-917-44) ",
"NDC11Code": "60687-0917-64",
"ProductNDC": "60687-917",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactulose",
"NonProprietaryName": "Lactulose",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20260816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090503",
"LabelerName": "American Health Packaging",
"SubstanceName": "LACTULOSE",
"StrengthNumber": "10",
"StrengthUnit": "g/15mL",
"Pharm_Classes": "Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260816",
"SamplePackage": "N",
"IndicationAndUsage": "For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.",
"Description": "Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O- β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular weight is 342 .30. It is freely soluble in water."
},
{
"NDCCode": "68462-341-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68462-341-01) ",
"NDC11Code": "68462-0341-01",
"ProductNDC": "68462-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090527",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090529",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6."
},
{
"NDCCode": "68462-341-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (68462-341-05) ",
"NDC11Code": "68462-0341-05",
"ProductNDC": "68462-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090527",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090529",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6."
},
{
"NDCCode": "68462-341-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (68462-341-10) ",
"NDC11Code": "68462-0341-10",
"ProductNDC": "68462-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090527",
"LabelerName": "Glenmark Pharmaceuticals Inc., USA",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090529",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6."
},
{
"NDCCode": "72789-341-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-341-90) ",
"NDC11Code": "72789-0341-90",
"ProductNDC": "72789-341",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202862",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230801",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg)."
},
{
"NDCCode": "60687-244-67",
"PackageDescription": "5 TRAY in 1 CASE (60687-244-67) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) ",
"NDC11Code": "60687-0244-67",
"ProductNDC": "60687-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077849",
"LabelerName": "American Health Packaging",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180601",
"EndMarketingDatePackage": "20230531",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine oral solution, USP is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .",
"Description": "Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 µmol) of fluoxetine. It also contains the following inactive ingredients: alcohol 0.23%, benzoic acid, spearmint flavor, glycerin, purified water, and sucrose."
},
{
"NDCCode": "60687-244-77",
"PackageDescription": "4 TRAY in 1 CASE (60687-244-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) ",
"NDC11Code": "60687-0244-77",
"ProductNDC": "60687-244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"EndMarketingDate": "20241031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077849",
"LabelerName": "American Health Packaging",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190115",
"EndMarketingDatePackage": "20241031",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine oral solution, USP is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .",
"Description": "Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 µmol) of fluoxetine. It also contains the following inactive ingredients: alcohol 0.23%, benzoic acid, spearmint flavor, glycerin, purified water, and sucrose."
},
{
"NDCCode": "60687-299-25",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-299-25) / 1 CAPSULE in 1 BLISTER PACK (60687-299-95) ",
"NDC11Code": "60687-0299-25",
"ProductNDC": "60687-299",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Itraconazole",
"NonProprietaryName": "Itraconazole",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205080",
"LabelerName": "American Health Packaging",
"SubstanceName": "ITRACONAZOLE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170502",
"SamplePackage": "N",
"IndicationAndUsage": "Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: : 1 Blastomycosis, pulmonary and extrapulmonary, 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and, 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.",
"Description": "Itraconazole, USP is an azole antifungal agent. Itraconazole, USP is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 R*,4 S*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one mixture with (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 S*,4 R*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. or. (±)-1-[( RS)- sec-butyl]-4-[ p-[4-[ p-[[(2 R,4 S)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. Itraconazole, USP has a molecular formula of C 35H 38Cl 2N 8O 4 and a molecular weight of 705.64. It is a white or almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres. Inactive ingredients are black iron oxide, FD&C Blue No. 1, gelatin, hypromellose, liquid glucose, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, starch (of maize), strong ammonia solution, sucrose and titanium dioxide."
},
{
"NDCCode": "60687-481-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) / 1 TABLET in 1 BLISTER PACK (60687-481-11) ",
"NDC11Code": "60687-0481-21",
"ProductNDC": "60687-481",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20200206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207276",
"LabelerName": "American Health Packaging",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200206",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine Sublingual Tablets are supplied as white to off white, round flat-faced beveled edged tablets debossed with \"RP\" on one side and an alphanumeric word identifying product and strength on the other side. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP, respectively). Each tablet also contains lactose monohydrate, povidone K29/32, anhydrous citric acid, trisodium citrate dihydrate, corn starch, mannitol, crospovidone, and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane."
},
{
"NDCCode": "60687-492-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-492-21) / 1 TABLET in 1 BLISTER PACK (60687-492-11) ",
"NDC11Code": "60687-0492-21",
"ProductNDC": "60687-492",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buprenorphine",
"NonProprietaryName": "Buprenorphine",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20200206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207276",
"LabelerName": "American Health Packaging",
"SubstanceName": "BUPRENORPHINE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200206",
"SamplePackage": "N",
"IndicationAndUsage": "Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.",
"Description": "Buprenorphine Sublingual Tablets are supplied as white to off white, round flat-faced beveled edged tablets debossed with \"RP\" on one side and an alphanumeric word identifying product and strength on the other side. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP, respectively). Each tablet also contains lactose monohydrate, povidone K29/32, anhydrous citric acid, trisodium citrate dihydrate, corn starch, mannitol, crospovidone, and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane."
},
{
"NDCCode": "60687-659-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (60687-659-01) / 1 CAPSULE in 1 BLISTER PACK (60687-659-11) ",
"NDC11Code": "60687-0659-01",
"ProductNDC": "60687-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220721",
"EndMarketingDate": "20270630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078619",
"LabelerName": "American Health Packaging",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220721",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine capsules are indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "60687-845-77",
"PackageDescription": "4 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40) ",
"NDC11Code": "60687-0845-77",
"ProductNDC": "60687-845",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20241204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079209",
"LabelerName": "American Health Packaging",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241204",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine oral solution is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .",
"Description": "Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, sucrose, glycerin, benzoic acid, natural peppermint flavor, and purified water."
},
{
"NDCCode": "0003-3622-12",
"PackageDescription": "30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12) ",
"NDC11Code": "00003-3622-12",
"ProductNDC": "0003-3622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Reyataz",
"NonProprietaryName": "Atazanavir",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030624",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021567",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ATAZANAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030624",
"SamplePackage": "N",
"IndicationAndUsage": "REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].",
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"Description": "The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor."
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"Description": "The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor."
},
{
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"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol."
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{
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"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol."
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{
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"Description": "The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol."
}
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<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<EndMarketingDatePackage>20230331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-341-71</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-341-71) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-341-44) </PackageDescription>
<NDC11Code>60687-0341-71</NDC11Code>
<ProductNDC>60687-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180901</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210041</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180901</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-341-72</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-341-72) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-341-51) > 30 mL in 1 CUP, UNIT-DOSE (60687-341-45) </PackageDescription>
<NDC11Code>60687-0341-72</NDC11Code>
<ProductNDC>60687-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180901</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210041</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180901</StartMarketingDatePackage>
<EndMarketingDatePackage>20230630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-616-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-616-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-616-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-616-44) </PackageDescription>
<NDC11Code>60687-0616-64</NDC11Code>
<ProductNDC>60687-616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211022</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211022</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1, 1 1-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>60687-628-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-628-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-628-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-628-44) </PackageDescription>
<NDC11Code>60687-0628-64</NDC11Code>
<ProductNDC>60687-628</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220228</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220311</StartMarketingDatePackage>
<EndMarketingDatePackage>20261031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-714-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-714-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-714-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-714-44) </PackageDescription>
<NDC11Code>60687-0714-64</NDC11Code>
<ProductNDC>60687-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate, 0.12% Oral Rinse</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate, 0.12% Oral Rinse</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20230614</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075561</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1, 1'-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Chlorhexidine gluconate product is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>60687-870-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-870-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-870-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-870-44) </PackageDescription>
<NDC11Code>60687-0870-64</NDC11Code>
<ProductNDC>60687-870</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20250918</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216780</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution 2% (Viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution USP, 2% (Viscous) contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C 14H 22N 2O. The molecular weight is 234.34.</Description>
</NDC>
<NDC>
<NDCCode>60687-884-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-884-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-884-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-884-44) </PackageDescription>
<NDC11Code>60687-0884-64</NDC11Code>
<ProductNDC>60687-884</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride Oral</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211648</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250421</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride oral solution is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.</IndicationAndUsage>
<Description>Potassium chloride, USP is a white crystalline powder or colorless crystals. It is freely soluble in water and practically insoluble in ethanol. Chemically, potassium chloride, USP is K-Cl with a molecular mass of 74.55. Oral Solution 10%: Each 15 mL of solution contains 1.5 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6, glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose. Oral Solution 20%: Each 15 mL of solution contains 3.0 g of potassium chloride, USP and the following inactive ingredients: citric acid anhydrous, FD&C Yellow No. 6,glycerin, methylparaben, natural & artificial orange flavor, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucralose.</Description>
</NDC>
<NDC>
<NDCCode>60687-917-64</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-917-64) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-917-50) / 15 mL in 1 CUP, UNIT-DOSE (60687-917-44) </PackageDescription>
<NDC11Code>60687-0917-64</NDC11Code>
<ProductNDC>60687-917</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactulose</ProprietaryName>
<NonProprietaryName>Lactulose</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090503</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>LACTULOSE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/15mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.</IndicationAndUsage>
<Description>Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O- β-D-galactopyranosyl-D-fructofuranose. It has the following structural formula:. The molecular weight is 342 .30. It is freely soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68462-341-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68462-341-01) </PackageDescription>
<NDC11Code>68462-0341-01</NDC11Code>
<ProductNDC>68462-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090527</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>68462-341-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (68462-341-05) </PackageDescription>
<NDC11Code>68462-0341-05</NDC11Code>
<ProductNDC>68462-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090527</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>68462-341-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (68462-341-10) </PackageDescription>
<NDC11Code>68462-0341-10</NDC11Code>
<ProductNDC>68462-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090527</ApplicationNumber>
<LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets, USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4HCl. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid and FDC Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>72789-341-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-341-90) </PackageDescription>
<NDC11Code>72789-0341-90</NDC11Code>
<ProductNDC>72789-341</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202862</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20230801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the:. · Treatment of schizophrenia. ( 1.1). · Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). · Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). · Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). · Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). · Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). · Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). · Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). · Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the: Treatment of depressive episodes associated with bipolar I disorder. ( 1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine USP equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose. The color coating contains Titanium Dioxide (all strengths), FD&C Blue No. 2 indigo carmine Aluminum Lake (15 mg), or Synthetic Red Iron Oxide (20 mg).</Description>
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<NDC>
<NDCCode>60687-244-67</NDCCode>
<PackageDescription>5 TRAY in 1 CASE (60687-244-67) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) > 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) </PackageDescription>
<NDC11Code>60687-0244-67</NDC11Code>
<ProductNDC>60687-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077849</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<EndMarketingDatePackage>20230531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine oral solution, USP is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
<Description>Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 µmol) of fluoxetine. It also contains the following inactive ingredients: alcohol 0.23%, benzoic acid, spearmint flavor, glycerin, purified water, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>60687-244-77</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-244-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-244-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-244-40) </PackageDescription>
<NDC11Code>60687-0244-77</NDC11Code>
<ProductNDC>60687-244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<EndMarketingDate>20241031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077849</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190115</StartMarketingDatePackage>
<EndMarketingDatePackage>20241031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine oral solution, USP is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
<Description>Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)- N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg per 5 mL (64.7 µmol) of fluoxetine. It also contains the following inactive ingredients: alcohol 0.23%, benzoic acid, spearmint flavor, glycerin, purified water, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>60687-299-25</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-299-25) / 1 CAPSULE in 1 BLISTER PACK (60687-299-95) </PackageDescription>
<NDC11Code>60687-0299-25</NDC11Code>
<ProductNDC>60687-299</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Itraconazole</ProprietaryName>
<NonProprietaryName>Itraconazole</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205080</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ITRACONAZOLE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: : 1 Blastomycosis, pulmonary and extrapulmonary, 2 Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and, 3 Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.</IndicationAndUsage>
<Description>Itraconazole, USP is an azole antifungal agent. Itraconazole, USP is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature. (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 R*,4 S*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one mixture with (±)-1-[( R*)- sec-butyl]-4-[ p-[4-[ p-[[(2 S*,4 R*)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. or. (±)-1-[( RS)- sec-butyl]-4-[ p-[4-[ p-[[(2 R,4 S)-2-(2,4-dichlorophenyl)-2-(1 H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy] phenyl]-1-piperazinyl]phenyl]-Δ 2-1,2,4-triazolin-5-one. Itraconazole, USP has a molecular formula of C 35H 38Cl 2N 8O 4 and a molecular weight of 705.64. It is a white or almost white powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1. Itraconazole capsules, USP contain 100 mg of itraconazole, USP coated on sugar spheres. Inactive ingredients are black iron oxide, FD&C Blue No. 1, gelatin, hypromellose, liquid glucose, microcrystalline cellulose, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate, starch (of maize), strong ammonia solution, sucrose and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60687-481-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-481-21) / 1 TABLET in 1 BLISTER PACK (60687-481-11) </PackageDescription>
<NDC11Code>60687-0481-21</NDC11Code>
<ProductNDC>60687-481</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20200206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207276</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine Sublingual Tablets are supplied as white to off white, round flat-faced beveled edged tablets debossed with "RP" on one side and an alphanumeric word identifying product and strength on the other side. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP, respectively). Each tablet also contains lactose monohydrate, povidone K29/32, anhydrous citric acid, trisodium citrate dihydrate, corn starch, mannitol, crospovidone, and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.</Description>
</NDC>
<NDC>
<NDCCode>60687-492-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-492-21) / 1 TABLET in 1 BLISTER PACK (60687-492-11) </PackageDescription>
<NDC11Code>60687-0492-21</NDC11Code>
<ProductNDC>60687-492</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buprenorphine</ProprietaryName>
<NonProprietaryName>Buprenorphine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20200206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207276</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>BUPRENORPHINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.</IndicationAndUsage>
<Description>Buprenorphine Sublingual Tablets are supplied as white to off white, round flat-faced beveled edged tablets debossed with "RP" on one side and an alphanumeric word identifying product and strength on the other side. They contain buprenorphine HCl, a partial agonist at the mu-opioid receptor, and are available in two dosage strengths, 2 mg buprenorphine and 8 mg buprenorphine (as the free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 8.64 mg buprenorphine hydrochloride USP, respectively). Each tablet also contains lactose monohydrate, povidone K29/32, anhydrous citric acid, trisodium citrate dihydrate, corn starch, mannitol, crospovidone, and magnesium stearate. Chemically, buprenorphine HCl is (2S)-2-[17-Cyclopropylmethyl-4,5α-epoxy-3-hydroxy-6-methoxy- 6α,14-ethano-14α-morphinan-7α-yl]-3,3-dimethylbutan-2-ol hydrochloride. It has the following chemical structure. Buprenorphine HCl has the molecular formula C 29H 41NO 4 HCl and the molecular weight is 504.10. It is a white or off-white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane.</Description>
</NDC>
<NDC>
<NDCCode>60687-659-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (60687-659-01) / 1 CAPSULE in 1 BLISTER PACK (60687-659-11) </PackageDescription>
<NDC11Code>60687-0659-01</NDC11Code>
<ProductNDC>60687-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220721</StartMarketingDate>
<EndMarketingDate>20270630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078619</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220721</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine capsules are indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #1, gelatin, pregelatinized starch (maize), sodium lauryl sulphate, titanium dioxide and yellow iron oxide. In addition 40 mg also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>60687-845-77</NDCCode>
<PackageDescription>4 TRAY in 1 CASE (60687-845-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-845-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-845-40) </PackageDescription>
<NDC11Code>60687-0845-77</NDC11Code>
<ProductNDC>60687-845</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079209</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine oral solution is indicated for the treatment of: 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)]. , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)]. .</IndicationAndUsage>
<Description>Fluoxetine oral solution, USP is a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p-tolyl)oxy]propylamine hydrochloride and has the molecular formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. The oral solution contains fluoxetine hydrochloride equivalent to 20 mg/5 mL (64.7 μmol) of fluoxetine. It also contains alcohol 0.23%, sucrose, glycerin, benzoic acid, natural peppermint flavor, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0003-3622-12</NDCCode>
<PackageDescription>30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0003-3622-12) </PackageDescription>
<NDC11Code>00003-3622-12</NDC11Code>
<ProductNDC>0003-3622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Reyataz</ProprietaryName>
<NonProprietaryName>Atazanavir</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030624</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021567</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ATAZANAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REYATAZ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: 1 REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.</Description>
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<Description>The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.</Description>
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<Description>The active ingredient in REYATAZ capsules and oral powder is atazanavir sulfate, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula. Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3°C. REYATAZ Capsules are available for oral administration in strengths of 200 mg or 300 mg of atazanavir, which are equivalent to 227.8 mg or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol. REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.</Description>
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<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol.</Description>
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<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol.</Description>
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<IndicationAndUsage>Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: 1 Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)]., 2 Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)].</IndicationAndUsage>
<Description>The active ingredient in atazanavir capsules is atazanavir sulfate, USP, which is an HIV-1 protease inhibitor. The chemical name for atazanavir sulfate, USP is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8 hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13 pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Its molecular formula is C38H52N6O7●H2SO4, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate, USP has the following structural formula. Atazanavir sulfate, USP is a white to pale-yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 ± 3○C. Atazanavir capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, USP, respectively. The capsules contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: FD&C Blue No. 1, gelatin, and titanium dioxide. The 300 mg capsule shells also contain FD&C Red No. 40. The capsules are printed with black ink containing D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, iron oxide black, shellac, and may contain propylene glycol.</Description>
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