{
"NDC": [
{
"NDCCode": "0206-8852-16",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0206-8852-16) > 10 mL in 1 VIAL, SINGLE-USE (0206-8852-08) ",
"NDC11Code": "00206-8852-16",
"ProductNDC": "0206-8852",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zosyn",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19931101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050684",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": ".25; 2",
"StrengthUnit": "g/10mL; g/10mL",
"Pharm_Classes": "beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19931101",
"SamplePackage": "N"
},
{
"NDCCode": "0206-8854-16",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0206-8854-16) > 15 mL in 1 VIAL, SINGLE-USE (0206-8854-08) ",
"NDC11Code": "00206-8854-16",
"ProductNDC": "0206-8854",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zosyn",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19931101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050684",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": ".375; 3",
"StrengthUnit": "g/15mL; g/15mL",
"Pharm_Classes": "beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19931101",
"SamplePackage": "N"
},
{
"NDCCode": "0206-8855-16",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0206-8855-16) > 20 mL in 1 VIAL, SINGLE-USE (0206-8855-08) ",
"NDC11Code": "00206-8855-16",
"ProductNDC": "0206-8855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zosyn",
"NonProprietaryName": "Piperacillin Sodium And Tazobactam Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19931101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050684",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "TAZOBACTAM SODIUM; PIPERACILLIN SODIUM",
"StrengthNumber": ".5; 4",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19931101",
"SamplePackage": "N"
},
{
"NDCCode": "0485-0206-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) ",
"NDC11Code": "00485-0206-16",
"ProductNDC": "0485-0206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rynex Pse",
"NonProprietaryName": "Brompheniramine Maleate And Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110307",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "EDWARDS PHARMACEUTICALS, INC.",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110307",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion 'reduces swelling of nasal passages."
},
{
"NDCCode": "45737-206-16",
"PackageDescription": "473 mL in 1 BOTTLE (45737-206-16) ",
"NDC11Code": "45737-0206-16",
"ProductNDC": "45737-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bionel",
"NonProprietaryName": "Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Advanced Generic Corporation",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "15; 200; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20091001",
"SamplePackage": "N",
"IndicationAndUsage": "Other information. store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering. Warning:Phenylketonuric: Contains 19 mg of Phenylalanine per 5 mL (one teaspoonful) dose."
},
{
"NDCCode": "59630-206-16",
"PackageDescription": "1 BOTTLE in 1 CARTON (59630-206-16) > 473.2 mL in 1 BOTTLE",
"NDC11Code": "59630-0206-16",
"ProductNDC": "59630-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cuvposa",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100728",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022571",
"LabelerName": "Shionogi Pharma, Inc.",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2014-08-08"
},
{
"NDCCode": "62802-206-16",
"PackageDescription": "475 mL in 1 BOTTLE, SPRAY (62802-206-16)",
"NDC11Code": "62802-0206-16",
"ProductNDC": "62802-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No-ad Spf4 Dark Tanning Oil",
"NonProprietaryName": "Octinoxate, Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Sun & Skin Care Research, LLC",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "3; 2",
"StrengthUnit": "mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "63776-206-16",
"PackageDescription": "1 BOTTLE in 1 BOX (63776-206-16) > 100 mL in 1 BOTTLE",
"NDC11Code": "63776-0206-16",
"ProductNDC": "63776-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-hair",
"NonProprietaryName": "Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BIOTIN; BOS TAURUS PITUITARY GLAND; ESTRADIOL; ESTRIOL; GINKGO; INTERLEUKIN-3; PANTOTHENIC ACID; PORK COLLAGEN; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; ZINC",
"StrengthNumber": "200; 30; 200; 200; 200; 30; 200; 30; 200; 200; 30; 200; 200; 30; 30",
"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",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "Hair health, hair regeneration & support."
},
{
"NDCCode": "73069-206-16",
"PackageDescription": "12 VIAL, MULTI-DOSE in 1 BOX (73069-206-16) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0206-16",
"ProductNDC": "73069-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-hair",
"NonProprietaryName": "Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "PANTOTHENIC ACID; BIOTIN; ESTRADIOL; PORK COLLAGEN; ESTRIOL; GINKGO; INTERLEUKIN-3; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; THYROID, UNSPECIFIED; ZINC; BASIC FIBROBLAST GROWTH FACTOR (HUMAN)",
"StrengthNumber": "31; 31; 201; 201; 201; 31; 201; 201; 201; 201; 31; 201; 31; 31; 201",
"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",
"Pharm_Classes": "Progesterone [CS],Progesterone [EPC],Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "78902-206-16",
"PackageDescription": "500 mL in 1 BOTTLE (78902-206-16) ",
"NDC11Code": "78902-0206-16",
"ProductNDC": "78902-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nature Love Hand Wash",
"ProprietaryNameSuffix": "Lemon Verbena",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Jocott Brands, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "79413-206-16",
"PackageDescription": "473 mL in 1 BOTTLE (79413-206-16) ",
"NDC11Code": "79413-0206-16",
"ProductNDC": "79413-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quantum Medium Viscosity Gel Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200909",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Quantum Valve And Oilfield Solutions, Llc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200909",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0069-0206-02",
"PackageDescription": "10 SYRINGE in 1 CARTON (0069-0206-02) / .3 mL in 1 SYRINGE (0069-0206-01) ",
"NDC11Code": "00069-0206-02",
"ProductNDC": "0069-0206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fragmin",
"NonProprietaryName": "Dalteparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020287",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "DALTEPARIN SODIUM",
"StrengthNumber": "7500",
"StrengthUnit": "[iU]/.3mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150401",
"SamplePackage": "N",
"IndicationAndUsage": "FRAGMIN is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1), 2 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2), 3 Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3), 4 Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (1.4), 5 Limitations of UseFRAGMIN is not indicated for the acute treatment of VTE (1.5).",
"Description": "FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide [see Dosage and Administration (2.7) and How Supplied/Storage and Handling (16)]. Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is. Structural Formula."
},
{
"NDCCode": "55150-206-99",
"PackageDescription": "1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-206-99) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE",
"NDC11Code": "55150-0206-99",
"ProductNDC": "55150-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205779",
"LabelerName": "Eugia US LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "g/1",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC], Glycopeptides [CS]",
"Status": "Active",
"LastUpdate": "2024-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160329",
"SamplePackage": "N",
"IndicationAndUsage": "Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of Infection.",
"Description": "Vancomycin hydrochloride for injection, USP is a white or off-white to light tan sterile, lyophilized powder or cake, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). Vancomycin hydrochloride USP is a white or almost white, hygroscopic powder. The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)- ß -D-glucopyranosyl] oxy] -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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE."
},
{
"NDCCode": "55513-206-01",
"PackageDescription": "1 VIAL in 1 CARTON (55513-206-01) / 4 mL in 1 VIAL",
"NDC11Code": "55513-0206-01",
"ProductNDC": "55513-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvasi",
"NonProprietaryName": "Bevacizumab-awwb",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761028",
"LabelerName": "Amgen, Inc",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1), 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1)Limitations of Use: MVASI is not indicated for adjuvant treatment of colon cancer. (1.1), 3 Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2), 4 Recurrent glioblastoma in adults. (1.3), 5 Metastatic renal cell carcinoma in combination with interferon-alfa. (1.4), 6 Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. (1.5), 7 Epithelial ovarian, fallopian tube, or primary peritoneal cancer:in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection (1.6)in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6)in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease (1.6).",
"Description": "Bevacizumab-awwb is a vascular endothelial growth factor inhibitor. Bevacizumab-awwb is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-awwb has an approximate molecular weight of 149 kDa. Bevacizumab-awwb is produced in a mammalian cell (Chinese Hamster Ovary) expression system. MVASI (bevacizumab-awwb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial for intravenous use. MVASI contains bevacizumab-awwb at a concentration of 25 mg/mL in either 100 mg/4 mL or 400 mg/16 mL, single-dose vials. Each mL of solution contains 25 mg bevacizumab-awwb, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2."
},
{
"NDCCode": "55513-206-21",
"PackageDescription": "1 VIAL in 1 CARTON (55513-206-21) / 4 mL in 1 VIAL",
"NDC11Code": "55513-0206-21",
"ProductNDC": "55513-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mvasi",
"NonProprietaryName": "Bevacizumab-awwb",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761028",
"LabelerName": "Amgen, Inc",
"SubstanceName": "BEVACIZUMAB",
"StrengthNumber": "100",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250627",
"SamplePackage": "N",
"IndicationAndUsage": "MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1), 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1)Limitations of Use: MVASI is not indicated for adjuvant treatment of colon cancer. (1.1), 3 Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2), 4 Recurrent glioblastoma in adults. (1.3), 5 Metastatic renal cell carcinoma in combination with interferon-alfa. (1.4), 6 Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. (1.5), 7 Epithelial ovarian, fallopian tube, or primary peritoneal cancer:in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection (1.6)in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6)in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease (1.6).",
"Description": "Bevacizumab-awwb is a vascular endothelial growth factor inhibitor. Bevacizumab-awwb is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-awwb has an approximate molecular weight of 149 kDa. Bevacizumab-awwb is produced in a mammalian cell (Chinese Hamster Ovary) expression system. MVASI (bevacizumab-awwb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial for intravenous use. MVASI contains bevacizumab-awwb at a concentration of 25 mg/mL in either 100 mg/4 mL or 400 mg/16 mL, single-dose vials. Each mL of solution contains 25 mg bevacizumab-awwb, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2."
},
{
"NDCCode": "59779-206-25",
"PackageDescription": "110 BLISTER PACK in 1 CARTON (59779-206-25) > 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "59779-0206-25",
"ProductNDC": "59779-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20070125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078325",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-10-16"
},
{
"NDCCode": "61197-206-00",
"PackageDescription": "50 mg in 1 TUBE (61197-206-00) ",
"NDC11Code": "61197-0206-00",
"ProductNDC": "61197-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Plus Skincare Spf 30 Mineral Face Shade Coconut Probiotic",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230123",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Pacifica Beauty, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "16",
"StrengthUnit": "g/100mg",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230123",
"SamplePackage": "N",
"IndicationAndUsage": "If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "61477-206-14",
"PackageDescription": "177 mL in 1 CAN (61477-206-14) ",
"NDC11Code": "61477-0206-14",
"ProductNDC": "61477-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Up Lil Kids Continuous Sunscreen",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140224",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Aloe Care International, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "3; 10; 5; 2.75; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140224",
"SamplePackage": "N"
},
{
"NDCCode": "62135-206-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (62135-206-01) ",
"NDC11Code": "62135-0206-01",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-206-18",
"PackageDescription": "180 TABLET in 1 BOTTLE (62135-206-18) ",
"NDC11Code": "62135-0206-18",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-206-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (62135-206-30) ",
"NDC11Code": "62135-0206-30",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "62135-206-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (62135-206-90) ",
"NDC11Code": "62135-0206-90",
"ProductNDC": "62135-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040411",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211104",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:."
},
{
"NDCCode": "64380-206-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64380-206-01) ",
"NDC11Code": "64380-0206-01",
"ProductNDC": "64380-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220919",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065070",
"LabelerName": "Strides Pharma Science Limited",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220919",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.",
"Description": "Doxycycline, USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg and 50 mg tablets contain doxycycline monohydrate equivalent to 150 mg, 100 mg, 75 mg or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients include colloidal silicon dioxide, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide. In addition, Doxycycline 100 mg and 50 mg tablets contain hypromellose 3cP, hypromellose 6cP, D&C yellow #10 lake, polyethylene glycol 400, polysorbate 80; Doxycycline 75 mg and 150 mg tablets contain hypromellose 15cP, lactose monohydrate, yellow iron oxide and triethyl citrate. Its molecular weight is 462.46."
},
{
"NDCCode": "65628-206-05",
"PackageDescription": "1 KIT in 1 CARTON (65628-206-05) * 7.5 g in 1 BOTTLE * 145 mL in 1 BOTTLE",
"NDC11Code": "65628-0206-05",
"ProductNDC": "65628-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Firvanq",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20180126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208910",
"LabelerName": "Azurity Pharmaceuticals, Inc",
"Status": "Active",
"LastUpdate": "2026-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180126",
"SamplePackage": "N",
"IndicationAndUsage": "FIRVANQ is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.",
"Description": "FIRVANQ for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose."
},
{
"NDCCode": "71288-206-02",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01) ",
"NDC11Code": "71288-0206-02",
"ProductNDC": "71288-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprostadil",
"NonProprietaryName": "Alprostadil",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20240915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075196",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ALPROSTADIL",
"StrengthNumber": "500",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2024-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240915",
"SamplePackage": "N",
"IndicationAndUsage": "Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. Alprostadil injection, USP should be administered only by trained personnel in facilities that provide pediatric intensive care.",
"Description": "Alprostadil injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Alprostadil has a molecular formula of C20H34O5."
},
{
"NDCCode": "81565-206-02",
"PackageDescription": "10 VIAL in 1 CARTON (81565-206-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (81565-206-01) ",
"NDC11Code": "81565-0206-02",
"ProductNDC": "81565-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vecuronium Bromide",
"NonProprietaryName": "Vecuronium Bromide",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190801",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203725",
"LabelerName": "Phlow Corp.",
"SubstanceName": "VECURONIUM BROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230111",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.",
"Description": "Vecuronium Bromide for Injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.73. Vecuronium Bromide for Injection is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each vial contains 10 mg or 20 mg of vecuronium bromide, USP. In addition, each 10 mg vial contains 20.75 mg citric acid anhydrous, 16.25 mg dibasic sodium phosphate anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Each 20 mg vial contains 41.5 mg citric acid anhydrous, 32.5 mg dibasic sodium phosphate anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5."
},
{
"NDCCode": "81806-206-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (81806-206-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "81806-0206-30",
"ProductNDC": "81806-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Deflazacort",
"NonProprietaryName": "Deflazacort",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250612",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219254",
"LabelerName": "Doppel Farmaceutici S.r.l.",
"SubstanceName": "DEFLAZACORT",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250612",
"SamplePackage": "N",
"IndicationAndUsage": "Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.",
"Description": "The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch."
},
{
"NDCCode": "84126-206-20",
"PackageDescription": "207 mL in 1 BOTTLE, PLASTIC (84126-206-20) ",
"NDC11Code": "84126-0206-20",
"ProductNDC": "84126-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Native Mineral Suncare Zinc Oxide Sunscreen Pear And Coconut Water Broad Spectrum Spf 30",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251211",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "17",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "85766-206-05",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (85766-206-05) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "85766-0206-05",
"ProductNDC": "85766-206",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRA-ARTICULAR; INTRAMUSCULAR",
"StartMarketingDate": "20171211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207550",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260507",
"SamplePackage": "N",
"IndicationAndUsage": "Intramuscular. Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscularuseas follows:. Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases:Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders:Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases:To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders:Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous:Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases:For the palliative management of leukemias and lymphomas. Nervous system:Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases:Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases:To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases:Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders:As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Intra-Articular. The intra-articular or soft tissue administrationof triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.",
"Description": "Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide, USP occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol."
},
{
"NDCCode": "98132-206-03",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (98132-206-03) / 3 mL in 1 BOTTLE, GLASS",
"NDC11Code": "98132-0206-03",
"ProductNDC": "98132-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20",
"ProprietaryNameSuffix": "Cashmere 06",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Orveon Global US LLC",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "33.2",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170801",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0206-8852-16</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0206-8852-16) > 10 mL in 1 VIAL, SINGLE-USE (0206-8852-08) </PackageDescription>
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<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
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<StartMarketingDate>19931101</StartMarketingDate>
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<ApplicationNumber>NDA050684</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
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<Pharm_Classes>beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0206-8854-16</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0206-8854-16) > 15 mL in 1 VIAL, SINGLE-USE (0206-8854-08) </PackageDescription>
<NDC11Code>00206-8854-16</NDC11Code>
<ProductNDC>0206-8854</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zosyn</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19931101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050684</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>.375; 3</StrengthNumber>
<StrengthUnit>g/15mL; g/15mL</StrengthUnit>
<Pharm_Classes>beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0206-8855-16</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0206-8855-16) > 20 mL in 1 VIAL, SINGLE-USE (0206-8855-08) </PackageDescription>
<NDC11Code>00206-8855-16</NDC11Code>
<ProductNDC>0206-8855</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zosyn</ProprietaryName>
<NonProprietaryName>Piperacillin Sodium And Tazobactam Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19931101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050684</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>TAZOBACTAM SODIUM; PIPERACILLIN SODIUM</SubstanceName>
<StrengthNumber>.5; 4</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC],Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19931101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0485-0206-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0485-0206-16) </PackageDescription>
<NDC11Code>00485-0206-16</NDC11Code>
<ProductNDC>0485-0206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rynex Pse</ProprietaryName>
<NonProprietaryName>Brompheniramine Maleate And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110307</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>EDWARDS PHARMACEUTICALS, INC.</LabelerName>
<SubstanceName>BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 15</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itching of the nose or throat, 4 itchy, watery eyes, 5 nasal congestion 'reduces swelling of nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>45737-206-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (45737-206-16) </PackageDescription>
<NDC11Code>45737-0206-16</NDC11Code>
<ProductNDC>45737-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bionel</ProprietaryName>
<NonProprietaryName>Dextromethorphan, Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Advanced Generic Corporation</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15; 200; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Other information. store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering. Warning:Phenylketonuric: Contains 19 mg of Phenylalanine per 5 mL (one teaspoonful) dose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59630-206-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59630-206-16) > 473.2 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>59630-0206-16</NDC11Code>
<ProductNDC>59630-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cuvposa</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100728</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022571</ApplicationNumber>
<LabelerName>Shionogi Pharma, Inc.</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-08-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>62802-206-16</NDCCode>
<PackageDescription>475 mL in 1 BOTTLE, SPRAY (62802-206-16)</PackageDescription>
<NDC11Code>62802-0206-16</NDC11Code>
<ProductNDC>62802-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No-ad Spf4 Dark Tanning Oil</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Sun & Skin Care Research, LLC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>3; 2</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-206-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63776-206-16) > 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63776-0206-16</NDC11Code>
<ProductNDC>63776-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-hair</ProprietaryName>
<NonProprietaryName>Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BIOTIN; BOS TAURUS PITUITARY GLAND; ESTRADIOL; ESTRIOL; GINKGO; INTERLEUKIN-3; PANTOTHENIC ACID; PORK COLLAGEN; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; ZINC</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 200; 30; 200; 30; 200; 200; 30; 200; 200; 30; 30</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</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hair health, hair regeneration & support.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>73069-206-16</NDCCode>
<PackageDescription>12 VIAL, MULTI-DOSE in 1 BOX (73069-206-16) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0206-16</NDC11Code>
<ProductNDC>73069-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-hair</ProprietaryName>
<NonProprietaryName>Pantothenic Acid , Biotin , Estradiol , Pork Collagen , Estriol , Heptaminol , Interleukin-3 , Bos Taurus Pituitary Gland , Sus Scrofa Pituitary Gland , Progesterone , Saw Palmetto , Silicon Dioxide , Thyroid, Unspecified And Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PANTOTHENIC ACID; BIOTIN; ESTRADIOL; PORK COLLAGEN; ESTRIOL; GINKGO; INTERLEUKIN-3; BOS TAURUS PITUITARY GLAND; SUS SCROFA PITUITARY GLAND; PROGESTERONE; SAW PALMETTO; SILICON DIOXIDE; THYROID, UNSPECIFIED; ZINC; BASIC FIBROBLAST GROWTH FACTOR (HUMAN)</SubstanceName>
<StrengthNumber>31; 31; 201; 201; 201; 31; 201; 201; 201; 201; 31; 201; 31; 31; 201</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</StrengthUnit>
<Pharm_Classes>Progesterone [CS],Progesterone [EPC],Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>78902-206-16</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (78902-206-16) </PackageDescription>
<NDC11Code>78902-0206-16</NDC11Code>
<ProductNDC>78902-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nature Love Hand Wash</ProprietaryName>
<ProprietaryNameSuffix>Lemon Verbena</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Jocott Brands, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR HAND WASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79413-206-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (79413-206-16) </PackageDescription>
<NDC11Code>79413-0206-16</NDC11Code>
<ProductNDC>79413-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quantum Medium Viscosity Gel Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200909</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Quantum Valve And Oilfield Solutions, Llc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0069-0206-02</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (0069-0206-02) / .3 mL in 1 SYRINGE (0069-0206-01) </PackageDescription>
<NDC11Code>00069-0206-02</NDC11Code>
<ProductNDC>0069-0206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fragmin</ProprietaryName>
<NonProprietaryName>Dalteparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020287</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>DALTEPARIN SODIUM</SubstanceName>
<StrengthNumber>7500</StrengthNumber>
<StrengthUnit>[iU]/.3mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FRAGMIN is a low molecular weight heparin (LMWH) indicated for: 1 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1), 2 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2), 3 Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3), 4 Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) (1.4), 5 Limitations of UseFRAGMIN is not indicated for the acute treatment of VTE (1.5).</IndicationAndUsage>
<Description>FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial. Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide [see Dosage and Administration (2.7) and How Supplied/Storage and Handling (16)]. Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is. Structural Formula.</Description>
</NDC>
<NDC>
<NDCCode>55150-206-99</NDCCode>
<PackageDescription>1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-206-99) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE</PackageDescription>
<NDC11Code>55150-0206-99</NDC11Code>
<ProductNDC>55150-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205779</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC], Glycopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures. Vancomycin hydrochloride for injection, USP has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin hydrochloride for injection, USP has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin hydrochloride for injection, USP has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. The parenteral form of vancomycin hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of Infection.</IndicationAndUsage>
<Description>Vancomycin hydrochloride for injection, USP is a white or off-white to light tan sterile, lyophilized powder or cake, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis). Vancomycin hydrochloride USP is a white or almost white, hygroscopic powder. The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)- ß -D-glucopyranosyl] oxy] -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-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula. A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE.</Description>
</NDC>
<NDC>
<NDCCode>55513-206-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (55513-206-01) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>55513-0206-01</NDC11Code>
<ProductNDC>55513-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvasi</ProprietaryName>
<NonProprietaryName>Bevacizumab-awwb</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761028</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1), 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1)Limitations of Use: MVASI is not indicated for adjuvant treatment of colon cancer. (1.1), 3 Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2), 4 Recurrent glioblastoma in adults. (1.3), 5 Metastatic renal cell carcinoma in combination with interferon-alfa. (1.4), 6 Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. (1.5), 7 Epithelial ovarian, fallopian tube, or primary peritoneal cancer:in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection (1.6)in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6)in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease (1.6).</IndicationAndUsage>
<Description>Bevacizumab-awwb is a vascular endothelial growth factor inhibitor. Bevacizumab-awwb is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-awwb has an approximate molecular weight of 149 kDa. Bevacizumab-awwb is produced in a mammalian cell (Chinese Hamster Ovary) expression system. MVASI (bevacizumab-awwb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial for intravenous use. MVASI contains bevacizumab-awwb at a concentration of 25 mg/mL in either 100 mg/4 mL or 400 mg/16 mL, single-dose vials. Each mL of solution contains 25 mg bevacizumab-awwb, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2.</Description>
</NDC>
<NDC>
<NDCCode>55513-206-21</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (55513-206-21) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>55513-0206-21</NDC11Code>
<ProductNDC>55513-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mvasi</ProprietaryName>
<NonProprietaryName>Bevacizumab-awwb</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761028</ApplicationNumber>
<LabelerName>Amgen, Inc</LabelerName>
<SubstanceName>BEVACIZUMAB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA], Vascular Endothelial Growth Factor-directed Antibody Interactions [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: 1 Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. (1.1), 2 Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. (1.1)Limitations of Use: MVASI is not indicated for adjuvant treatment of colon cancer. (1.1), 3 Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. (1.2), 4 Recurrent glioblastoma in adults. (1.3), 5 Metastatic renal cell carcinoma in combination with interferon-alfa. (1.4), 6 Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. (1.5), 7 Epithelial ovarian, fallopian tube, or primary peritoneal cancer:in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection (1.6)in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6)in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease (1.6).</IndicationAndUsage>
<Description>Bevacizumab-awwb is a vascular endothelial growth factor inhibitor. Bevacizumab-awwb is a recombinant humanized monoclonal IgG1 antibody that contains human framework regions and murine complementarity-determining regions. Bevacizumab-awwb has an approximate molecular weight of 149 kDa. Bevacizumab-awwb is produced in a mammalian cell (Chinese Hamster Ovary) expression system. MVASI (bevacizumab-awwb) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial for intravenous use. MVASI contains bevacizumab-awwb at a concentration of 25 mg/mL in either 100 mg/4 mL or 400 mg/16 mL, single-dose vials. Each mL of solution contains 25 mg bevacizumab-awwb, α,α-trehalose dihydrate (60 mg), polysorbate 20 (0.4 mg), sodium phosphate dibasic, anhydrous (1.2 mg), sodium phosphate monobasic, monohydrate (5.8 mg), and Water for Injection, USP. The pH is 6.2.</Description>
</NDC>
<NDC>
<NDCCode>59779-206-25</NDCCode>
<PackageDescription>110 BLISTER PACK in 1 CARTON (59779-206-25) > 1 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59779-0206-25</NDC11Code>
<ProductNDC>59779-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078325</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-16</LastUpdate>
</NDC>
<NDC>
<NDCCode>61197-206-00</NDCCode>
<PackageDescription>50 mg in 1 TUBE (61197-206-00) </PackageDescription>
<NDC11Code>61197-0206-00</NDC11Code>
<ProductNDC>61197-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Plus Skincare Spf 30 Mineral Face Shade Coconut Probiotic</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Pacifica Beauty, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/100mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61477-206-14</NDCCode>
<PackageDescription>177 mL in 1 CAN (61477-206-14) </PackageDescription>
<NDC11Code>61477-0206-14</NDC11Code>
<ProductNDC>61477-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Up Lil Kids Continuous Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140224</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Aloe Care International, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>3; 10; 5; 2.75; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62135-206-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62135-206-01) </PackageDescription>
<NDC11Code>62135-0206-01</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-206-18</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (62135-206-18) </PackageDescription>
<NDC11Code>62135-0206-18</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-206-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (62135-206-30) </PackageDescription>
<NDC11Code>62135-0206-30</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>62135-206-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (62135-206-90) </PackageDescription>
<NDC11Code>62135-0206-90</NDC11Code>
<ProductNDC>62135-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040411</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets, USP are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Each tablet contains 5 mg or 10 mg (43.8 mcmol or 87.6 mcmol) methimazole USP, an orally administered antithyroid drug. Each tablet also contains anhydrous lactose, colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch (corn) and talc. The molecular weight is 114.16, and the molecular formula is C 4H 6N 2S. The structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>64380-206-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64380-206-01) </PackageDescription>
<NDC11Code>64380-0206-01</NDC11Code>
<ProductNDC>64380-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220919</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065070</ApplicationNumber>
<LabelerName>Strides Pharma Science Limited</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections. Rocky mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (ornithosis) caused by Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Uncomplicated urethral, endocervical or rectal infections in adults caused by Chlamydia trachomatis. Nongonococcal urethritis caused by Ureaplasma urealyticum. Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug. Escherichia coli. Enterobacter aerogenes. Shigella species. Acinetobacter species. Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug. Upper respiratory infections caused by Streptococcus pneumoniae. Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections. Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum. Yaws caused by Treponema pallidum subspecies pertenue. Listeriosis due to Listeria monocytogenes. Vincent's infection caused by Fusobacterium fusiforme. Actinomycosis caused by Actinomyces israelii. Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy.</IndicationAndUsage>
<Description>Doxycycline, USP is a broad-spectrum antibacterial synthetically derived from oxytetracycline. Doxycycline 150 mg, 100 mg, 75 mg and 50 mg tablets contain doxycycline monohydrate equivalent to 150 mg, 100 mg, 75 mg or 50 mg of doxycycline for oral administration. The chemical designation of the light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline. Structural formula. C22H24N2O8H2O M.W. = 462.45. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Inactive ingredients include colloidal silicon dioxide, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide. In addition, Doxycycline 100 mg and 50 mg tablets contain hypromellose 3cP, hypromellose 6cP, D&C yellow #10 lake, polyethylene glycol 400, polysorbate 80; Doxycycline 75 mg and 150 mg tablets contain hypromellose 15cP, lactose monohydrate, yellow iron oxide and triethyl citrate. Its molecular weight is 462.46.</Description>
</NDC>
<NDC>
<NDCCode>65628-206-05</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (65628-206-05) * 7.5 g in 1 BOTTLE * 145 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>65628-0206-05</NDC11Code>
<ProductNDC>65628-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Firvanq</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208910</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FIRVANQ is indicated for the treatment of Clostridium difficile‑associated diarrhea in adults and pediatric patients less than 18 years of age. FIRVANQ is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus(including methicillin‑resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use: 1 Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections., 2 Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections.</IndicationAndUsage>
<Description>FIRVANQ for oral administration contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis(formerly Nocardia orientalis), which has the chemical formula C 66H 75Cl 2N 9O 24HCl. The molecular weight of vancomycin hydrochloride is 1485.71 g/mol. Vancomycin hydrochloride has the structural formula. Each FIRVANQ kit contains a bottle of vancomycin hydrochloride USP, as white to almost white or tan to brown powder for oral solution, and a bottle of pre‑measured Grape‑Flavored Diluent, in the strengths and volumes listed in Table 3. The Grape‑Flavored Diluent used to reconstitute the oral solution contains: artificial grape flavor, citric acid (anhydrous), D&C Yellow No. 10, FD&C Red No. 40, purified water, sodium benzoate and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>71288-206-02</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01) </PackageDescription>
<NDC11Code>71288-0206-02</NDC11Code>
<ProductNDC>71288-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprostadil</ProprietaryName>
<NonProprietaryName>Alprostadil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20240915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075196</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALPROSTADIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increase in blood oxygenation is inversely proportional to pretreatment pO2 values; that is, patients with low pO2 values respond best, and patients with pO2 values of 40 torr or more usually have little response. Alprostadil injection, USP should be administered only by trained personnel in facilities that provide pediatric intensive care.</IndicationAndUsage>
<Description>Alprostadil injection, USP for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E1, in 1 mL dehydrated alcohol. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Alprostadil has a molecular formula of C20H34O5.</Description>
</NDC>
<NDC>
<NDCCode>81565-206-02</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (81565-206-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (81565-206-01) </PackageDescription>
<NDC11Code>81565-0206-02</NDC11Code>
<ProductNDC>81565-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vecuronium Bromide</ProprietaryName>
<NonProprietaryName>Vecuronium Bromide</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190801</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203725</ApplicationNumber>
<LabelerName>Phlow Corp.</LabelerName>
<SubstanceName>VECURONIUM BROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230111</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.</IndicationAndUsage>
<Description>Vecuronium Bromide for Injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. The structural formula is. Its chemical formula is C34H57BrN2O4 with molecular weight 637.73. Vecuronium Bromide for Injection is supplied as a sterile nonpyrogenic freeze-dried buffered cake of very fine microscopic crystalline particles for intravenous injection only. Each vial contains 10 mg or 20 mg of vecuronium bromide, USP. In addition, each 10 mg vial contains 20.75 mg citric acid anhydrous, 16.25 mg dibasic sodium phosphate anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Each 20 mg vial contains 41.5 mg citric acid anhydrous, 32.5 mg dibasic sodium phosphate anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5.</Description>
</NDC>
<NDC>
<NDCCode>81806-206-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (81806-206-30) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>81806-0206-30</NDC11Code>
<ProductNDC>81806-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Deflazacort</ProprietaryName>
<NonProprietaryName>Deflazacort</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250612</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219254</ApplicationNumber>
<LabelerName>Doppel Farmaceutici S.r.l.</LabelerName>
<SubstanceName>DEFLAZACORT</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Deflazacort tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.</IndicationAndUsage>
<Description>The active ingredient in deflazacort tablets is deflazacort (a corticosteroid). Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic. The molecular formula for deflazacort is C 25H 31NO 6. The chemical name for deflazacort is (11β,16β)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'H-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, and the structural formula is:. Deflazacort is a white to pale yellow crystalline powder and has a molecular weight of 441.5. Deflazacort is freely soluble in acetic acid and dichloromethane and sparingly soluble in methanol and acetone. Deflazacort tablets for oral administration is available as an immediate-release tablet in strengths of 6, 18, 30 and 36 mg. Each tablet contains deflazacort and the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>84126-206-20</NDCCode>
<PackageDescription>207 mL in 1 BOTTLE, PLASTIC (84126-206-20) </PackageDescription>
<NDC11Code>84126-0206-20</NDC11Code>
<ProductNDC>84126-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Native Mineral Suncare Zinc Oxide Sunscreen Pear And Coconut Water Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251211</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>17</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85766-206-05</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (85766-206-05) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>85766-0206-05</NDC11Code>
<ProductNDC>85766-206</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRAMUSCULAR</RouteName>
<StartMarketingDate>20171211</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207550</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Intramuscular. Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscularuseas follows:. Allergic states:Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases:Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders:Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases:To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders:Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous:Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases:For the palliative management of leukemias and lymphomas. Nervous system:Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases:Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases:To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases:Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders:As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Intra-Articular. The intra-articular or soft tissue administrationof triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.</IndicationAndUsage>
<Description>Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80 in an aqueous suspension. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is. MW 434.50. Triamcinolone acetonide, USP occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.</Description>
</NDC>
<NDC>
<NDCCode>98132-206-03</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (98132-206-03) / 3 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>98132-0206-03</NDC11Code>
<ProductNDC>98132-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bareminerals Barepro Performance Wear Liquid Foundation Broad Spectrum Spf 20</ProprietaryName>
<ProprietaryNameSuffix>Cashmere 06</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Orveon Global US LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>33.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
</NDCList>