{
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{
"NDCCode": "51811-300-44",
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"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-400-44",
"PackageDescription": ".236 L in 1 BOTTLE, PLASTIC (51811-400-44) ",
"NDC11Code": "51811-0400-44",
"ProductNDC": "51811-400",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "700",
"StrengthUnit": "mg/L",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100913",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Recommended for repeated use."
},
{
"NDCCode": "51811-300-20",
"PackageDescription": "29 mL in 1 BOTTLE, PUMP (51811-300-20) ",
"NDC11Code": "51811-0300-20",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-21",
"PackageDescription": "29 mL in 1 BOTTLE, PLASTIC (51811-300-21) ",
"NDC11Code": "51811-0300-21",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-25",
"PackageDescription": "29 mL in 1 BOTTLE, PLASTIC (51811-300-25) ",
"NDC11Code": "51811-0300-25",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-31",
"PackageDescription": "59 mL in 1 BOTTLE, PLASTIC (51811-300-31) ",
"NDC11Code": "51811-0300-31",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-40",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (51811-300-40) ",
"NDC11Code": "51811-0300-40",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-41",
"PackageDescription": "118 mL in 1 BOTTLE, PUMP (51811-300-41) ",
"NDC11Code": "51811-0300-41",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-45",
"PackageDescription": "236 mL in 1 BOTTLE, PUMP (51811-300-45) ",
"NDC11Code": "51811-0300-45",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-50",
"PackageDescription": "473 mL in 1 BOTTLE, PUMP (51811-300-50) ",
"NDC11Code": "51811-0300-50",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20101220",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-51",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (51811-300-51) ",
"NDC11Code": "51811-0300-51",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "51811-300-52",
"PackageDescription": "473 mL in 1 BOTTLE, PUMP (51811-300-52) ",
"NDC11Code": "51811-0300-52",
"ProductNDC": "51811-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimicrobial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "HPC Ventures, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201001",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin. Fecommended for repeated use."
},
{
"NDCCode": "33342-300-44",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-300-44) ",
"NDC11Code": "33342-0300-44",
"ProductNDC": "33342-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eszopiclone",
"NonProprietaryName": "Eszopiclone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202929",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "ESZOPICLONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2022-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150131",
"SamplePackage": "N",
"IndicationAndUsage": "Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).",
"Description": "Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17CIN6O3. Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2."
},
{
"NDCCode": "64893-300-00",
"PackageDescription": "44 mL in 1 TUBE (64893-300-00) ",
"NDC11Code": "64893-0300-00",
"ProductNDC": "64893-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Firefly Mouth Swoosh Anti-cavity Fluoride Rinse",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "LIQUID",
"RouteName": "DENTAL",
"StartMarketingDate": "20100902",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Dr. Fresh LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100902",
"SamplePackage": "N"
},
{
"NDCCode": "65753-100-44",
"PackageDescription": "300 PACKET in 1 BOX (65753-100-44) > 7 mL in 1 PACKET",
"NDC11Code": "65753-0100-44",
"ProductNDC": "65753-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coretex Sun X Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130125",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CoreTex Products",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE",
"StrengthNumber": "1; 5; 7.5; 5; 6",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130125",
"SamplePackage": "N"
},
{
"NDCCode": "65753-106-44",
"PackageDescription": "300 PACKET in 1 BOX (65753-106-44) > 7 mL in 1 PACKET",
"NDC11Code": "65753-0106-44",
"ProductNDC": "65753-106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coretex Sun X Spf 30 New",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210107",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CoreTex Products",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 7; 5; 5",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210107",
"SamplePackage": "N"
},
{
"NDCCode": "73069-300-44",
"PackageDescription": "6 VIAL, MULTI-DOSE in 1 BOX (73069-300-44) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0300-44",
"ProductNDC": "73069-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-liver",
"NonProprietaryName": "Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CENTAUREA BENEDICTA; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE",
"StrengthNumber": "31; 31; 4; 31; 4; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 31; 201; 201; 31; 31; 31; 31; 31; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190505",
"SamplePackage": "N"
},
{
"NDCCode": "73272-300-01",
"PackageDescription": "1 KIT in 1 CARTON (73272-300-01) * 35.44 g in 1 TUBE * 89 mL in 1 BOTTLE",
"NDC11Code": "73272-0300-01",
"ProductNDC": "73272-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidostream",
"NonProprietaryName": "Lidocaine 5% Ointment And Menthol 10% Topical Liquid",
"DosageFormName": "KIT",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205318",
"LabelerName": "Upstream Pharma, LLC",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.",
"Description": "Lidocaine Ointment USP 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment USP 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula. Composition of Lidocaine Ointment USP, 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-(lidocaine) 5% in water miscible ointment vehicle containing polyethylene glycol 300 and polyethylene glycol 1450."
},
{
"NDCCode": "78310-300-05",
"PackageDescription": ".44 kg in 1 BOTTLE (78310-300-05) ",
"NDC11Code": "78310-0300-05",
"ProductNDC": "78310-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B Clean Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "HETH LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "60",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "79793-001-44",
"PackageDescription": "300 mL in 1 BOTTLE, PUMP (79793-001-44) ",
"NDC11Code": "79793-0001-44",
"ProductNDC": "79793-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boogoo Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200724",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Ningbo Wingspan Commodity Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200724",
"SamplePackage": "N",
"IndicationAndUsage": "hand sanitizer to help decrease bacteria on the skin that may cause disease."
},
{
"NDCCode": "81877-300-80",
"PackageDescription": "1 KIT in 1 CARTON (81877-300-80) * 80 g in 1 TUBE (67877-251-80) * 118 mL in 1 TUBE (53329-152-44) ",
"NDC11Code": "81877-0300-80",
"ProductNDC": "81877-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triadime",
"NonProprietaryName": "Triamcinolone Acetonide Cream .1%, Dimethicone 5% Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20230504",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ForReal Pharmaceuticals",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230504",
"SamplePackage": "N",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is. Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate."
},
{
"NDCCode": "0003-2291-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "00003-2291-11",
"ProductNDC": "0003-2291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Empliciti",
"NonProprietaryName": "Elotuzumab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761035",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ELOTUZUMAB",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151130",
"SamplePackage": "N",
"IndicationAndUsage": "EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.",
"Description": "Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6)]. Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg)."
},
{
"NDCCode": "0003-4522-11",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (0003-4522-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE",
"NDC11Code": "00003-4522-11",
"ProductNDC": "0003-4522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Empliciti",
"NonProprietaryName": "Elotuzumab",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761035",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "ELOTUZUMAB",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151130",
"SamplePackage": "N",
"IndicationAndUsage": "EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.",
"Description": "Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6)]. Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg)."
},
{
"NDCCode": "0024-5761-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE",
"NDC11Code": "00024-5761-01",
"ProductNDC": "0024-5761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soliqua 100/33",
"NonProprietaryName": "Insulin Glargine And Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208673",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE; LIXISENATIDE",
"StrengthNumber": "100; 33",
"StrengthUnit": "U/mL; ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5."
},
{
"NDCCode": "0024-5761-05",
"PackageDescription": "5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02) ",
"NDC11Code": "00024-5761-05",
"ProductNDC": "0024-5761",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soliqua 100/33",
"NonProprietaryName": "Insulin Glargine And Lixisenatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20161121",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA208673",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "INSULIN GLARGINE; LIXISENATIDE",
"StrengthNumber": "100; 33",
"StrengthUnit": "U/mL; ug/mL",
"Pharm_Classes": "GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161121",
"SamplePackage": "N",
"IndicationAndUsage": "SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5."
},
{
"NDCCode": "0143-9466-06",
"PackageDescription": "6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01) ",
"NDC11Code": "00143-9466-06",
"ProductNDC": "0143-9466",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyzavan",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "1.25",
"StrengthUnit": "g/250mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
"NDCCode": "0143-9467-06",
"PackageDescription": "6 BAG in 1 CARTON (0143-9467-06) / 350 mL in 1 BAG (0143-9467-01) ",
"NDC11Code": "00143-9467-06",
"ProductNDC": "0143-9467",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyzavan",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "1.75",
"StrengthUnit": "g/350mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
"NDCCode": "0143-9468-06",
"PackageDescription": "6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) ",
"NDC11Code": "00143-9468-06",
"ProductNDC": "0143-9468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyzavan",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/150mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
"NDCCode": "0143-9468-12",
"PackageDescription": "12 BAG in 1 CARTON (0143-9468-12) / 150 mL in 1 BAG (0143-9468-01) ",
"NDC11Code": "00143-9468-12",
"ProductNDC": "0143-9468",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyzavan",
"NonProprietaryName": "Vancomycin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20251017",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211962",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "VANCOMYCIN",
"StrengthNumber": "750",
"StrengthUnit": "mg/150mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251017",
"SamplePackage": "N",
"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
},
{
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"ProductNDC": "0143-9469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyzavan",
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"IndicationAndUsage": "TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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": "TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L."
}
]
}
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<Description>Eszopiclone, USP is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is C17H17CIN6O3. Eszopiclone, USP has a single chiral center with an (S)-configuration. It has the following chemical structure. Eszopiclone, USP is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2). Eszopiclone, USP is formulated as film-coated tablets for oral administration. Eszopiclone tablets, USP contain 1 mg, 2 mg, or 3 mg eszopiclone, USP and the following inactive ingredients: dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.</Description>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Firefly Mouth Swoosh Anti-cavity Fluoride Rinse</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>Dr. Fresh LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65753-100-44</NDCCode>
<PackageDescription>300 PACKET in 1 BOX (65753-100-44) > 7 mL in 1 PACKET</PackageDescription>
<NDC11Code>65753-0100-44</NDC11Code>
<ProductNDC>65753-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coretex Sun X Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CoreTex Products</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
<StrengthNumber>1; 5; 7.5; 5; 6</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65753-106-44</NDCCode>
<PackageDescription>300 PACKET in 1 BOX (65753-106-44) > 7 mL in 1 PACKET</PackageDescription>
<NDC11Code>65753-0106-44</NDC11Code>
<ProductNDC>65753-106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coretex Sun X Spf 30 New</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CoreTex Products</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 7; 5; 5</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73069-300-44</NDCCode>
<PackageDescription>6 VIAL, MULTI-DOSE in 1 BOX (73069-300-44) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0300-44</NDC11Code>
<ProductNDC>73069-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-liver</ProprietaryName>
<NonProprietaryName>Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CENTAUREA BENEDICTA; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE</SubstanceName>
<StrengthNumber>31; 31; 4; 31; 4; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 31; 201; 201; 31; 31; 31; 31; 31; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73272-300-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (73272-300-01) * 35.44 g in 1 TUBE * 89 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>73272-0300-01</NDC11Code>
<ProductNDC>73272-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidostream</ProprietaryName>
<NonProprietaryName>Lidocaine 5% Ointment And Menthol 10% Topical Liquid</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205318</ApplicationNumber>
<LabelerName>Upstream Pharma, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.</IndicationAndUsage>
<Description>Lidocaine Ointment USP 5% contains a local anesthetic agent and is administered topically. See INDICATIONS AND USAGE for specific uses. Lidocaine Ointment USP 5% contains lidocaine, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, and has the following structural formula. Composition of Lidocaine Ointment USP, 5%: acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-(lidocaine) 5% in water miscible ointment vehicle containing polyethylene glycol 300 and polyethylene glycol 1450.</Description>
</NDC>
<NDC>
<NDCCode>78310-300-05</NDCCode>
<PackageDescription>.44 kg in 1 BOTTLE (78310-300-05) </PackageDescription>
<NDC11Code>78310-0300-05</NDC11Code>
<ProductNDC>78310-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>B Clean Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>HETH LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79793-001-44</NDCCode>
<PackageDescription>300 mL in 1 BOTTLE, PUMP (79793-001-44) </PackageDescription>
<NDC11Code>79793-0001-44</NDC11Code>
<ProductNDC>79793-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boogoo Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200724</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Ningbo Wingspan Commodity Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>hand sanitizer to help decrease bacteria on the skin that may cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81877-300-80</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (81877-300-80) * 80 g in 1 TUBE (67877-251-80) * 118 mL in 1 TUBE (53329-152-44) </PackageDescription>
<NDC11Code>81877-0300-80</NDC11Code>
<ProductNDC>81877-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triadime</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide Cream .1%, Dimethicone 5% Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230504</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ForReal Pharmaceuticals</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its structural formula is. Each gram of triamcinolone acetonide cream contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.</Description>
</NDC>
<NDC>
<NDCCode>0003-2291-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00003-2291-11</NDC11Code>
<ProductNDC>0003-2291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Empliciti</ProprietaryName>
<NonProprietaryName>Elotuzumab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761035</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ELOTUZUMAB</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.</IndicationAndUsage>
<Description>Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6)]. Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg).</Description>
</NDC>
<NDC>
<NDCCode>0003-4522-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (0003-4522-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>00003-4522-11</NDC11Code>
<ProductNDC>0003-4522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Empliciti</ProprietaryName>
<NonProprietaryName>Elotuzumab</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761035</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>ELOTUZUMAB</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], SLAMF7-directed Antibody Interactions [MoA], SLAMF7-directed Immunostimulatory Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.</IndicationAndUsage>
<Description>Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks. Elotuzumab is produced in NS0 cells by recombinant DNA technology. Elotuzumab has a theoretical mass of 148.1 kDa for the intact antibody. EMPLICITI (elotuzumab) is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake in single-dose vials. EMPLICITI for Injection is supplied as 300 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300 mg) and 16 mL (400 mg). The reconstituted solution is colorless to slightly yellow, clear to slightly opalescent. Prior to intravenous infusion, the reconstituted solution is diluted with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP [see Dosage and Administration (2.6)]. Each 300 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg), and sucrose (510 mg). Each 400 mg single-dose vial of EMPLICITI also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg), and sucrose (660 mg).</Description>
</NDC>
<NDC>
<NDCCode>0024-5761-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00024-5761-01</NDC11Code>
<ProductNDC>0024-5761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soliqua 100/33</ProprietaryName>
<NonProprietaryName>Insulin Glargine And Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208673</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE; LIXISENATIDE</SubstanceName>
<StrengthNumber>100; 33</StrengthNumber>
<StrengthUnit>U/mL; ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0024-5761-05</NDCCode>
<PackageDescription>5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02) </PackageDescription>
<NDC11Code>00024-5761-05</NDC11Code>
<ProductNDC>0024-5761</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soliqua 100/33</ProprietaryName>
<NonProprietaryName>Insulin Glargine And Lixisenatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20161121</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA208673</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>INSULIN GLARGINE; LIXISENATIDE</SubstanceName>
<StrengthNumber>100; 33</StrengthNumber>
<StrengthUnit>U/mL; ug/mL</StrengthUnit>
<Pharm_Classes>GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Insulin Analog [EPC], Insulin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble. It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa. SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0143-9466-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9466-06) / 250 mL in 1 BAG (0143-9466-01) </PackageDescription>
<NDC11Code>00143-9466-06</NDC11Code>
<ProductNDC>0143-9466</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>g/250mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0143-9467-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9467-06) / 350 mL in 1 BAG (0143-9467-01) </PackageDescription>
<NDC11Code>00143-9467-06</NDC11Code>
<ProductNDC>0143-9467</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>1.75</StrengthNumber>
<StrengthUnit>g/350mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0143-9468-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) </PackageDescription>
<NDC11Code>00143-9468-06</NDC11Code>
<ProductNDC>0143-9468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/150mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0143-9468-12</NDCCode>
<PackageDescription>12 BAG in 1 CARTON (0143-9468-12) / 150 mL in 1 BAG (0143-9468-01) </PackageDescription>
<NDC11Code>00143-9468-12</NDC11Code>
<ProductNDC>0143-9468</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/150mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0143-9469-06</NDCCode>
<PackageDescription>6 BAG in 1 CARTON (0143-9469-06) / 300 mL in 1 BAG (0143-9469-01) </PackageDescription>
<NDC11Code>00143-9469-06</NDC11Code>
<ProductNDC>0143-9469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyzavan</ProprietaryName>
<NonProprietaryName>Vancomycin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20251017</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211962</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>VANCOMYCIN</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/300mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TYZAVAN is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) 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>TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags contain vancomycin as vancomycin hydrochloride. It is a tricyclic glycopeptide antibacterial drug derived from Amycolatopsis orientalis (formerly Nocardia orientalis). The chemical name 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(iminometha-no)-13,16:31,35-dimetheno-1H,16H-[1,6,9]-oxadiazacyclohexadecino-[4,5-m][10,2,16]-benzoxa-diazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24HCl and the molecular weight is 1,485.71. Vancomycin hydrochloride has the following structural formula. TYZAVAN (Vancomycin Injection, USP), in single-dose flexible bags are sterile, nonpyrogenic premixed 100 mL, 150 mL, 200 mL, 250 mL, 300 mL, 350 mL or 400 mL solution containing 500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g or 2 g vancomycin, respectively, as vancomycin hydrochloride. Each 100 mL of solution contains 1.36 g N-acetyl-D-alanine, 1.26 g L-lysine hydrochloride (monochloride) in water for injection. Hydrochloric acid and sodium hydroxide are used for pH adjustment. The pH is 4.5 to 5.5 and the osmolarity is 350 to 475 mOsmol/L.</Description>
</NDC>
</NDCList>