{
"NDC": [
{
"NDCCode": "35000-769-71",
"PackageDescription": "39.6 g in 1 CONTAINER (35000-769-71) ",
"NDC11Code": "35000-0769-71",
"ProductNDC": "35000-769",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Speed Stick",
"ProprietaryNameSuffix": "Invisible Dry Power",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "105",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "12634-769-71",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (12634-769-71)",
"NDC11Code": "12634-0769-71",
"ProductNDC": "12634-769",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciprofloxacin",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076558",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "CIPROFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Ciprofloxacin Tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and people population listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.",
"Description": "Ciprofloxacin Tablets, USP is a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion (methylacrylate and ethylacrylate copolymer), polyethylene glycol, purified water, simethicone emulsion, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "35000-002-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-002-71) > 204 g in 1 TUBE",
"NDC11Code": "35000-0002-71",
"ProductNDC": "35000-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Total Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20100920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
"StrengthNumber": "1.4; 3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "35000-003-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-003-71) > 119 g in 1 TUBE",
"NDC11Code": "35000-0003-71",
"ProductNDC": "35000-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20100810",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
"StrengthNumber": "1.4; 3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20101021",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "35000-021-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-021-71) > 119 g in 1 TUBE",
"NDC11Code": "35000-0021-71",
"ProductNDC": "35000-021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Clean Mint",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20101130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
"StrengthNumber": "1.1; 3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20101130",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "35000-210-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-210-71) > 119 g in 1 TUBE",
"NDC11Code": "35000-0210-71",
"ProductNDC": "35000-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Hydris Dry Mouth",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20171201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.4",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20171201",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "35000-261-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-261-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0261-71",
"ProductNDC": "35000-261",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Stain Fighter Clean Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20220601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220601",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-262-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-262-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0262-71",
"ProductNDC": "35000-262",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Charcoal",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20220601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220601",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-263-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-263-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0263-71",
"ProductNDC": "35000-263",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Stain Fighter Fresh Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20220601",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "COLGATE PALMOLIVE COMPANY",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220601",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-419-58",
"PackageDescription": "1 TUBE in 1 CARTON (35000-419-58) / 71 g in 1 TUBE",
"NDC11Code": "35000-0419-58",
"ProductNDC": "35000-419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tp Col Ow Purple",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N"
},
{
"NDCCode": "35000-419-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-419-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0419-71",
"ProductNDC": "35000-419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tp Col Ow Purple",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20231001",
"EndMarketingDate": "20271101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20231001",
"EndMarketingDatePackage": "20271101",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-767-71",
"PackageDescription": "39.6 g in 1 CONTAINER (35000-767-71) ",
"NDC11Code": "35000-0767-71",
"ProductNDC": "35000-767",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ladies Speed Stick Invisible Dry",
"ProprietaryNameSuffix": "Powder Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "104",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251202",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "35000-771-71",
"PackageDescription": "39.6 g in 1 CONTAINER (35000-771-71) ",
"NDC11Code": "35000-0771-71",
"ProductNDC": "35000-771",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lady Speed Stick Invisible Dry",
"ProprietaryNameSuffix": "Shower Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "105",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "35000-781-71",
"PackageDescription": "39.6 g in 1 CONTAINER (35000-781-71) ",
"NDC11Code": "35000-0781-71",
"ProductNDC": "35000-781",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ladies Speed Stick Invisible Dry",
"ProprietaryNameSuffix": "Powder Fresh",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260222",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "105",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260222",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "35000-916-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-916-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0916-71",
"ProductNDC": "35000-916",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ultra Brite Baking Soda And Peroxide Whitening",
"ProprietaryNameSuffix": "Cool Mint",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20111201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-917-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-917-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0917-71",
"ProductNDC": "35000-917",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Ultra Brite Advanced Whitening All In One Clean Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20051116",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-936-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-936-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0936-71",
"ProductNDC": "35000-936",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Stain Fighter Fresh Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20171130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "COLGATE PALMOLIVE COMPANY",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171130",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-937-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-937-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0937-71",
"ProductNDC": "35000-937",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Stain Fighter Clean Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20171130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "COLGATE PALMOLIVE COMPANY",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171130",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-953-71",
"PackageDescription": "119 g in 1 TUBE (35000-953-71) ",
"NDC11Code": "35000-0953-71",
"ProductNDC": "35000-953",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Cavity Protection",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20140406",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140406",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-978-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-978-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0978-71",
"ProductNDC": "35000-978",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Advanced Sparkling White",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20191014",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191126",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-983-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-983-71) > 119 g in 1 TUBE",
"NDC11Code": "35000-0983-71",
"ProductNDC": "35000-983",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Zero For Kids",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20191209",
"EndMarketingDate": "20220606",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191209",
"EndMarketingDatePackage": "20220606",
"SamplePackage": "N"
},
{
"NDCCode": "35000-988-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-988-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0988-71",
"ProductNDC": "35000-988",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Charcoal",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20200505",
"EndMarketingDate": "20271201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200505",
"EndMarketingDatePackage": "20271201",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-998-71",
"PackageDescription": "1 TUBE in 1 CARTON (35000-998-71) / 119 g in 1 TUBE",
"NDC11Code": "35000-0998-71",
"ProductNDC": "35000-998",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Optic White Stain Fighter Sens Relief",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20221101",
"EndMarketingDate": "20271101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; POTASSIUM NITRATE",
"StrengthNumber": "1.5; 50",
"StrengthUnit": "mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20221101",
"EndMarketingDatePackage": "20271101",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "0143-9161-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9161-10) / 513 mg in 1 VIAL (0143-9161-01) ",
"NDC11Code": "00143-9161-10",
"ProductNDC": "0143-9161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "513",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241203",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9161-25",
"PackageDescription": "25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) ",
"NDC11Code": "00143-9161-25",
"ProductNDC": "0143-9161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "513",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9162-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01) ",
"NDC11Code": "00143-9162-10",
"ProductNDC": "0143-9162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20230202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1025",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230202",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9473-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9473-10) / 769 mg in 1 VIAL (0143-9473-01) ",
"NDC11Code": "00143-9473-10",
"ProductNDC": "0143-9473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20250813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "769",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250813",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9474-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9474-10) / 1280 mg in 1 VIAL (0143-9474-01) ",
"NDC11Code": "00143-9474-10",
"ProductNDC": "0143-9474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20250813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1280",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250813",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0143-9475-10",
"PackageDescription": "10 VIAL in 1 PACKAGE (0143-9475-10) / 1540 mg in 1 VIAL (0143-9475-01) ",
"NDC11Code": "00143-9475-10",
"ProductNDC": "0143-9475",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS; ORAL",
"StartMarketingDate": "20250813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210274",
"LabelerName": "HIKMA PHARMACEUTICALS USA INC.",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1540",
"StrengthUnit": "mg/mg",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250813",
"SamplePackage": "N",
"Description": "Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)]."
},
{
"NDCCode": "0338-0122-04",
"PackageDescription": "250 mL in 1 BAG (0338-0122-04) ",
"NDC11Code": "00338-0122-04",
"ProductNDC": "0338-0122",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "19581114",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050671",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240125",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).",
"Description": "Vancomycin Injection USP, in the GALAXY plastic container contains vancomycin, added as Vancomycin Hydrochloride USP. It is a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name of vancomycin hydrochloride is (Sa)-(3S, 6R, 7R, 22R, 23S, 26S, 36R, 38aR)-44-[[2-O-(3-Amino-2, 3, 6-trideoxy-3-Cmethyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)- 10,19dichloro 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6[(2R)-4-methyl-2-(methylamino) valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno23, 36-(iminomethano)-13, 16:31, 35-dimetheno-1H, 16H-[l, 6, 9] oxadiazacyclohexadecino [4, 5-m] [10, 2, 16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24·HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Injection, USP in the GALAXY container is a frozen, iso-osmotic, sterile, nonpyrogenic, premixed single-dose formulation. The composition of Vancomycin Injection, USP, available in the following strengths are: 1 500 mg/100 mL (5 mg/mL): containing 500 mg of vancomycin (equivalent to 513 mg of vancomycin hydrochloride); approximately 5 g of dextrose hydrous or 0.9 g of sodium chloride (equivalent to 354 mg total sodium content), 2 750 mg/150 mL (5 mg/mL): containing 750 mg of vancomycin (equivalent to 769 mg of vancomycin hydrochloride); approximately 7.5 g of dextrose hydrous or 1.35 g of sodium chloride (equivalent to 531 mg total sodium content), 3 1 g/200 mL (5 mg/mL): containing 1 g of vancomycin (equivalent to 1.025 g of vancomycin hydrochloride); approximately 10 g of dextrose hydrous or 1.8 g of sodium chloride (equivalent to 708 mg total sodium content), 4 1.25 g/250 mL (5 mg/mL): containing 1.25 g of vancomycin (equivalent to 1.281 g of vancomycin hydrochloride); approximately 12.5 g of dextrose hydrous., 5 1.5 g/300 mL (5 mg/mL): containing 1.5 g of vancomycin (equivalent to 1.538 g of vancomycin hydrochloride); approximately 15 g of dextrose hydrous."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>35000-769-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-769-71) </PackageDescription>
<NDC11Code>35000-0769-71</NDC11Code>
<ProductNDC>35000-769</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Speed Stick</ProprietaryName>
<ProprietaryNameSuffix>Invisible Dry Power</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12634-769-71</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (12634-769-71)</PackageDescription>
<NDC11Code>12634-0769-71</NDC11Code>
<ProductNDC>12634-769</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciprofloxacin</ProprietaryName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076558</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>CIPROFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ciprofloxacin Tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and people population listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.</IndicationAndUsage>
<Description>Ciprofloxacin Tablets, USP is a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17H 18FN 3O 3HClH 2O and its chemical structure is as follows:. Ciprofloxacin film-coated tablets are available in 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, corn starch, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion (methylacrylate and ethylacrylate copolymer), polyethylene glycol, purified water, simethicone emulsion, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>35000-002-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-002-71) > 204 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0002-71</NDC11Code>
<ProductNDC>35000-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Total Whitening</ProprietaryName>
<NonProprietaryName>Sodium Fluoride And Triclosan</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20100920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020231</ApplicationNumber>
<LabelerName>Colgate-Palmolive</LabelerName>
<SubstanceName>SODIUM FLUORIDE; TRICLOSAN</SubstanceName>
<StrengthNumber>1.4; 3</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>35000-003-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-003-71) > 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0003-71</NDC11Code>
<ProductNDC>35000-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate</ProprietaryName>
<ProprietaryNameSuffix>Total Whitening</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride And Triclosan</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20100810</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020231</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE; TRICLOSAN</SubstanceName>
<StrengthNumber>1.4; 3</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101021</StartMarketingDatePackage>
<EndMarketingDatePackage>20220101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35000-021-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-021-71) > 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0021-71</NDC11Code>
<ProductNDC>35000-021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate</ProprietaryName>
<ProprietaryNameSuffix>Total Clean Mint</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride And Triclosan</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20101130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020231</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE; TRICLOSAN</SubstanceName>
<StrengthNumber>1.1; 3</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101130</StartMarketingDatePackage>
<EndMarketingDatePackage>20220101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35000-210-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-210-71) > 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0210-71</NDC11Code>
<ProductNDC>35000-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Hydris Dry Mouth</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20171201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171201</StartMarketingDatePackage>
<EndMarketingDatePackage>20220101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35000-261-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-261-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0261-71</NDC11Code>
<ProductNDC>35000-261</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Stain Fighter Clean Mint</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20220601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-262-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-262-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0262-71</NDC11Code>
<ProductNDC>35000-262</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Charcoal</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20220601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-263-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-263-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0263-71</NDC11Code>
<ProductNDC>35000-263</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Stain Fighter Fresh Mint</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20220601</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>COLGATE PALMOLIVE COMPANY</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220601</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-419-58</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-419-58) / 71 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0419-58</NDC11Code>
<ProductNDC>35000-419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tp Col Ow Purple</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35000-419-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-419-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0419-71</NDC11Code>
<ProductNDC>35000-419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tp Col Ow Purple</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<EndMarketingDate>20271101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<EndMarketingDatePackage>20271101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-767-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-767-71) </PackageDescription>
<NDC11Code>35000-0767-71</NDC11Code>
<ProductNDC>35000-767</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ladies Speed Stick Invisible Dry</ProprietaryName>
<ProprietaryNameSuffix>Powder Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>104</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-771-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-771-71) </PackageDescription>
<NDC11Code>35000-0771-71</NDC11Code>
<ProductNDC>35000-771</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lady Speed Stick Invisible Dry</ProprietaryName>
<ProprietaryNameSuffix>Shower Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-781-71</NDCCode>
<PackageDescription>39.6 g in 1 CONTAINER (35000-781-71) </PackageDescription>
<NDC11Code>35000-0781-71</NDC11Code>
<ProductNDC>35000-781</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ladies Speed Stick Invisible Dry</ProprietaryName>
<ProprietaryNameSuffix>Powder Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>105</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-916-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-916-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0916-71</NDC11Code>
<ProductNDC>35000-916</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ultra Brite Baking Soda And Peroxide Whitening</ProprietaryName>
<ProprietaryNameSuffix>Cool Mint</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-917-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-917-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0917-71</NDC11Code>
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<PackageDescription>1 TUBE in 1 CARTON (35000-936-71) / 119 g in 1 TUBE</PackageDescription>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
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<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
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<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (35000-978-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0978-71</NDC11Code>
<ProductNDC>35000-978</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Advanced Sparkling White</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
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<ProductNDC>35000-983</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Zero For Kids</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
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<EndMarketingDate>20220606</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191209</StartMarketingDatePackage>
<EndMarketingDatePackage>20220606</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>35000-988-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-988-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0988-71</NDC11Code>
<ProductNDC>35000-988</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Charcoal</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20200505</StartMarketingDate>
<EndMarketingDate>20271201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200505</StartMarketingDatePackage>
<EndMarketingDatePackage>20271201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
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<NDC>
<NDCCode>35000-998-71</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35000-998-71) / 119 g in 1 TUBE</PackageDescription>
<NDC11Code>35000-0998-71</NDC11Code>
<ProductNDC>35000-998</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Colgate Optic White Stain Fighter Sens Relief</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20221101</StartMarketingDate>
<EndMarketingDate>20271101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE; POTASSIUM NITRATE</SubstanceName>
<StrengthNumber>1.5; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20221101</StartMarketingDatePackage>
<EndMarketingDatePackage>20271101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0143-9161-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9161-10) / 513 mg in 1 VIAL (0143-9161-01) </PackageDescription>
<NDC11Code>00143-9161-10</NDC11Code>
<ProductNDC>0143-9161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>513</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9161-25</NDCCode>
<PackageDescription>25 VIAL in 1 PACKAGE (0143-9161-25) / 513 mg in 1 VIAL (0143-9161-01) </PackageDescription>
<NDC11Code>00143-9161-25</NDC11Code>
<ProductNDC>0143-9161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>513</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9162-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9162-10) / 1025 mg in 1 VIAL (0143-9162-01) </PackageDescription>
<NDC11Code>00143-9162-10</NDC11Code>
<ProductNDC>0143-9162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20230202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1025</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9473-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9473-10) / 769 mg in 1 VIAL (0143-9473-01) </PackageDescription>
<NDC11Code>00143-9473-10</NDC11Code>
<ProductNDC>0143-9473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20250813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>769</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9474-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9474-10) / 1280 mg in 1 VIAL (0143-9474-01) </PackageDescription>
<NDC11Code>00143-9474-10</NDC11Code>
<ProductNDC>0143-9474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20250813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1280</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0143-9475-10</NDCCode>
<PackageDescription>10 VIAL in 1 PACKAGE (0143-9475-10) / 1540 mg in 1 VIAL (0143-9475-01) </PackageDescription>
<NDC11Code>00143-9475-10</NDC11Code>
<ProductNDC>0143-9475</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; ORAL</RouteName>
<StartMarketingDate>20250813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210274</ApplicationNumber>
<LabelerName>HIKMA PHARMACEUTICALS USA INC.</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1540</StrengthNumber>
<StrengthUnit>mg/mg</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Vancomycin Hydrochloride for Injection contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name for vancomycin hydrochloride is (Sa)-(3S,6R,7R,22R,23S,26S,36R,38aR)-44-[[2-O-(3-Amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2R)-4-methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[l,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Hydrochloride for Injection is a sterile, preservative-free, white, almost white to tan to brown, spray-dried powder, for preparing intravenous (IV) infusions, in single-dose vials each containing the equivalent of 500 mg, 750 mg, 1 g, 1.25 g or 1.5 g vancomycin base. Each 500 mg vial contains 500 mg vancomycin (equivalent to 513 mg vancomycin hydrochloride), 125 mg trehalose, 0.05 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 750 mg vial contains 750 mg vancomycin (equivalent to 769 mg vancomycin hydrochloride), 187.5 mg trehalose, 0.075 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1 g vial contains 1 g vancomycin (equivalent to 1.025 g vancomycin hydrochloride), 250 mg trehalose, 0.1 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.25 g vial contains 1.25 g vancomycin (equivalent to 1.28 g vancomycin hydrochloride), 312.5 mg trehalose, 0.125 mg polysorbate 80, and hydrochloric acid used to adjust the pH. Each 1.5 g vial contains 1.5 g vancomycin (equivalent to 1.54 g vancomycin hydrochloride), 375 mg trehalose, 0.15 mg polysorbate 80, and hydrochloric acid used to adjust the pH. The spray-dried powder is reconstituted with Sterile Water for Injection which forms a clear solution and subsequently diluted prior to intravenous or oral administration [see Dosage and Administration (2.5, 2.8)]. Vancomycin Hydrochloride for Injection may also be diluted with a sweetening agent for oral administration [see Dosage and Administration (2.8)].</Description>
</NDC>
<NDC>
<NDCCode>0338-0122-04</NDCCode>
<PackageDescription>250 mL in 1 BAG (0338-0122-04) </PackageDescription>
<NDC11Code>00338-0122-04</NDC11Code>
<ProductNDC>0338-0122</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>19581114</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050671</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin Injection is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: 1 Septicemia (1.1), 2 Infective Endocarditis (1.2), 3 Skin and Skin Structure Infections (1.3), 4 Bone Infections (1.4), 5 Lower Respiratory Tract Infections (1.5).</IndicationAndUsage>
<Description>Vancomycin Injection USP, in the GALAXY plastic container contains vancomycin, added as Vancomycin Hydrochloride USP. It is a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name of vancomycin hydrochloride is (Sa)-(3S, 6R, 7R, 22R, 23S, 26S, 36R, 38aR)-44-[[2-O-(3-Amino-2, 3, 6-trideoxy-3-Cmethyl-α-L-lyxo-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)- 10,19dichloro 2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6[(2R)-4-methyl-2-(methylamino) valeramido]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno23, 36-(iminomethano)-13, 16:31, 35-dimetheno-1H, 16H-[l, 6, 9] oxadiazacyclohexadecino [4, 5-m] [10, 2, 16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24·HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. Vancomycin Injection, USP in the GALAXY container is a frozen, iso-osmotic, sterile, nonpyrogenic, premixed single-dose formulation. The composition of Vancomycin Injection, USP, available in the following strengths are: 1 500 mg/100 mL (5 mg/mL): containing 500 mg of vancomycin (equivalent to 513 mg of vancomycin hydrochloride); approximately 5 g of dextrose hydrous or 0.9 g of sodium chloride (equivalent to 354 mg total sodium content), 2 750 mg/150 mL (5 mg/mL): containing 750 mg of vancomycin (equivalent to 769 mg of vancomycin hydrochloride); approximately 7.5 g of dextrose hydrous or 1.35 g of sodium chloride (equivalent to 531 mg total sodium content), 3 1 g/200 mL (5 mg/mL): containing 1 g of vancomycin (equivalent to 1.025 g of vancomycin hydrochloride); approximately 10 g of dextrose hydrous or 1.8 g of sodium chloride (equivalent to 708 mg total sodium content), 4 1.25 g/250 mL (5 mg/mL): containing 1.25 g of vancomycin (equivalent to 1.281 g of vancomycin hydrochloride); approximately 12.5 g of dextrose hydrous., 5 1.5 g/300 mL (5 mg/mL): containing 1.5 g of vancomycin (equivalent to 1.538 g of vancomycin hydrochloride); approximately 15 g of dextrose hydrous.</Description>
</NDC>
</NDCList>