{
"NDC": [
{
"NDCCode": "70626-105-13",
"PackageDescription": "100 mL in 1 TUBE (70626-105-13) ",
"NDC11Code": "70626-0105-13",
"ProductNDC": "70626-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Start So Fresh",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "ASPIRE BRANDS INC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N",
"IndicationAndUsage": "ACNE TREATMENT TO HELP CLEAR UP AND PREVENT NEW ACNE BLEMISHES, BLACKHEADS, AND WHITEHEADS."
},
{
"NDCCode": "70626-105-15",
"PackageDescription": "1 TUBE in 1 BOX (70626-105-15) > 15 mL in 1 TUBE",
"NDC11Code": "70626-0105-15",
"ProductNDC": "70626-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Start So Fresh",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201203",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "ASPIRE BRANDS INC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201203",
"SamplePackage": "N"
},
{
"NDCCode": "10889-105-13",
"PackageDescription": "1 STICK in 1 APPLICATOR (10889-105-13)",
"NDC11Code": "10889-0105-13",
"ProductNDC": "10889-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Walgreens Original",
"ProprietaryNameSuffix": "Antiperspirant Deodorant 2.7 Oz",
"NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20080404",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "VVF Kansas Services LLC",
"SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
"StrengthNumber": "16",
"StrengthUnit": "1/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For odor protection. Reduces underarm wetness. Turn dial to raise product. Remove plastic dome. Apply a thin even layer to underarms for maximum effectiveness. Do not over apply."
},
{
"NDCCode": "13537-105-14",
"PackageDescription": "1 TUBE in 1 BOX (13537-105-14) > 4 g in 1 TUBE (13537-105-13)",
"NDC11Code": "13537-0105-14",
"ProductNDC": "13537-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Couleur Luxe Rouge Irresistible Maximum Hydration Spf 17",
"ProprietaryNameSuffix": "(fuchsia Intense) - Purple",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".071; .016",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn. ."
},
{
"NDCCode": "51414-105-13",
"PackageDescription": "250 g in 1 BOTTLE (51414-105-13) ",
"NDC11Code": "51414-0105-13",
"ProductNDC": "51414-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mouthwash",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "RINSE",
"RouteName": "DENTAL",
"StartMarketingDate": "20160110",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Yuyao Jessie Commodity Co.,Ltd.",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": ".07",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-02-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20161115",
"SamplePackage": "N",
"IndicationAndUsage": "helps control plaque that leads to gingivitis and bleeding gums."
},
{
"NDCCode": "52536-105-13",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (52536-105-13) ",
"NDC11Code": "52536-0105-13",
"ProductNDC": "52536-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin",
"NonProprietaryName": "Erythromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061621",
"LabelerName": "Wilshire Pharmaceuticals",
"SubstanceName": "ERYTHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2019-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180315",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Tablets, USP and other antibacterial drugs, Erythromycin Tablets, 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. Erythromycin Tablets, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate- I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.3. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.3. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.",
"Description": "Erythromycin Tablets, USP are an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin Tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is."
},
{
"NDCCode": "57664-105-13",
"PackageDescription": "500 TABLET in 1 BOTTLE (57664-105-13)",
"NDC11Code": "57664-0105-13",
"ProductNDC": "57664-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Salsalate",
"NonProprietaryName": "Salsalate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19950401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "SALSALATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.",
"Description": "Salsalate, is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, salsalate (salicylsalicylic acid or 2-hydroxy-benzoic acid, 2- carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below. Each tablet, for oral administration contains 500 mg or 750 mg of salsalate, USP. In addition each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Povidone, and Stearic Acid. Also contains: Hydroxypropyl Methylcellulose, Polydextrose, Titanium Dioxide, Triacetin, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and Polyethylene Glycol."
},
{
"NDCCode": "64709-105-10",
"PackageDescription": ".13 g in 1 PACKET (64709-105-10) ",
"NDC11Code": "64709-0105-10",
"ProductNDC": "64709-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Wipe",
"NonProprietaryName": "Benzalkonium Chloride Wipe",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201105",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Diamond Wipes International",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201105",
"SamplePackage": "N",
"IndicationAndUsage": "■ for hand sanitizing to decrease bacteria on skin when water and soap are not available. ■ recommended for repeated use."
},
{
"NDCCode": "67492-105-13",
"PackageDescription": "25.5 g in 1 JAR (67492-105-13) ",
"NDC11Code": "67492-0105-13",
"ProductNDC": "67492-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Resinol",
"NonProprietaryName": "Petrolatum And Resorcinol",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20020629",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "ResiCal, Inc.",
"SubstanceName": "PETROLATUM; RESORCINOL",
"StrengthNumber": "55; 2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20020629",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily protects minor cutsscrapesburns. temporarily relieves pain and itching associated with minor skin irritationsminor burnssunburnminor cutsscrapesinsect bitesrashes due to poison ivy, oak, and sumac."
},
{
"NDCCode": "69452-105-13",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (69452-105-13) ",
"NDC11Code": "69452-0105-13",
"ProductNDC": "69452-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Montelukast",
"NonProprietaryName": "Montelukast",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141201",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202859",
"LabelerName": "Bionpharma Inc.",
"SubstanceName": "MONTELUKAST SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141201",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "76891-105-13",
"PackageDescription": "236 mL in 1 BOTTLE (76891-105-13) ",
"NDC11Code": "76891-0105-13",
"ProductNDC": "76891-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Born Basic. Anti-bac Hand Sanitizer",
"ProprietaryNameSuffix": "65 Percent",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191017",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SCENT THEORY PRODUCTS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "DECREASES BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE . RECOMMENDED FOR REPEATED USE."
},
{
"NDCCode": "82393-105-13",
"PackageDescription": "5 kg in 1 DRUM (82393-105-13) ",
"NDC11Code": "82393-0105-13",
"ProductNDC": "82393-105",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pregnenolone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20211209",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Pharma Source Direct, Inc.",
"SubstanceName": "PREGNENOLONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-01-08",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "09-DEC-21"
},
{
"NDCCode": "83589-105-13",
"PackageDescription": "250 g in 1 BAG (83589-105-13) ",
"NDC11Code": "83589-0105-13",
"ProductNDC": "83589-105",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cjc-1295",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250430",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "CJC-1295",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "30-APR-25"
},
{
"NDCCode": "84369-105-01",
"PackageDescription": "13 g in 1 BOX (84369-105-01) ",
"NDC11Code": "84369-0105-01",
"ProductNDC": "84369-105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skin Tag Patches",
"NonProprietaryName": "Skin Tag Patches",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240827",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M028",
"LabelerName": "Shenzhen Rongxing Trading Co., Ltd.",
"SubstanceName": "HAMAMELIS VIRGINIANA TOP WATER",
"StrengthNumber": "72",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240827",
"SamplePackage": "N",
"IndicationAndUsage": "For external use only. Avoid direct contact with eyes. Discontinue use if irritation occur. Keep out of reach of childeren. Store in a cool and dry place."
},
{
"NDCCode": "84502-105-13",
"PackageDescription": "500 g in 1 BOTTLE (84502-105-13) ",
"NDC11Code": "84502-0105-13",
"ProductNDC": "84502-105",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Retatrutide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250307",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Fujian Genohope Biotech Ltd.",
"SubstanceName": "RETATRUTIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "07-MAR-25"
},
{
"NDCCode": "84789-105-13",
"PackageDescription": "50 g in 1 BAG (84789-105-13) ",
"NDC11Code": "84789-0105-13",
"ProductNDC": "84789-105",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cjc-1295",
"DosageFormName": "POWDER",
"StartMarketingDate": "20240929",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Hangzhou XinHan Biopharma Co., Ltd.",
"SubstanceName": "CJC-1295",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-SEP-24"
},
{
"NDCCode": "0054-0449-49",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00054-0449-49",
"ProductNDC": "0054-0449",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Posaconazole",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208773",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230329",
"SamplePackage": "N",
"IndicationAndUsage": "Posaconazole is an azole antifungal indicated as follows: : 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in adults and pediatric patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. (1.2) , 2 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients aged 13 years and older. (1.3).",
"Description": "Posaconazole is an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white to off-white powder that is practically insoluble in water. Posaconazole oral suspension is a white to off-white, cherry-brandy flavored immediate-release suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: cherry-brandy flavor, citric acid monohydrate, hydroxyethyl cellulose, glycerin, polyoxyl 35 castor oil, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, titanium dioxide, and water."
},
{
"NDCCode": "0085-1328-01",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00085-1328-01",
"ProductNDC": "0085-1328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Noxafil",
"NonProprietaryName": "Posaconazole",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20060915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022003",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060915",
"SamplePackage": "N",
"IndicationAndUsage": "Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.",
"Description": "Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum."
},
{
"NDCCode": "0143-9666-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01) ",
"NDC11Code": "00143-9666-06",
"ProductNDC": "0143-9666",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078764",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9667-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) ",
"NDC11Code": "00143-9667-06",
"ProductNDC": "0143-9667",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078764",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9668-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9668-06) / 200 mL in 1 CONTAINER (0143-9668-01) ",
"NDC11Code": "00143-9668-06",
"ProductNDC": "0143-9668",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9668-10",
"PackageDescription": "10 CONTAINER in 1 CARTON (0143-9668-10) / 200 mL in 1 CONTAINER (0143-9668-01) ",
"NDC11Code": "00143-9668-10",
"ProductNDC": "0143-9668",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9669-06",
"PackageDescription": "6 CONTAINER in 1 CARTON (0143-9669-06) / 100 mL in 1 CONTAINER (0143-9669-01) ",
"NDC11Code": "00143-9669-06",
"ProductNDC": "0143-9669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120130",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9669-10",
"PackageDescription": "10 CONTAINER in 1 CARTON (0143-9669-10) / 100 mL in 1 CONTAINER (0143-9669-01) ",
"NDC11Code": "00143-9669-10",
"ProductNDC": "0143-9669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078698",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
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"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0143-9899-91",
"PackageDescription": "6 VIAL in 1 CARTON (0143-9899-91) / 100 mL in 1 VIAL (0143-9899-01) ",
"NDC11Code": "00143-9899-91",
"ProductNDC": "0143-9899",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076736",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
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"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20050823",
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"IndicationAndUsage": "Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .",
"Description": "Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 \"Indirect Food Additives\". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers."
},
{
"NDCCode": "0254-1016-36",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00254-1016-36",
"ProductNDC": "0254-1016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Posaconazole",
"NonProprietaryName": "Posaconazole",
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"RouteName": "ORAL",
"StartMarketingDate": "20230329",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
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"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "POSACONAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230329",
"SamplePackage": "N",
"IndicationAndUsage": "Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh greater than 40 kg. (1.1), 2 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgPosaconazole oral suspension: adults and pediatric patients 13 years of age and older, 3 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older. (1.3).",
"Description": "Posaconazole delayed-release tablets and Posaconazole oral suspension contain posaconazole; an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Posaconazole Delayed-Release Tablets. Posaconazole delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Posaconazole Oral Suspension. Posaconazole oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum."
},
{
"NDCCode": "0527-4116-37",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) ",
"NDC11Code": "00527-4116-37",
"ProductNDC": "0527-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0527-4116-41",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) ",
"NDC11Code": "00527-4116-41",
"ProductNDC": "0527-4116",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0527-4117-37",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4117-37) ",
"NDC11Code": "00527-4117-37",
"ProductNDC": "0527-4117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
},
{
"NDCCode": "0527-4117-41",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4117-41) ",
"NDC11Code": "00527-4117-41",
"ProductNDC": "0527-4117",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212026",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200106",
"SamplePackage": "N",
"IndicationAndUsage": "Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.",
"Description": "Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol)."
}
]
}
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<NDC>
<NDCCode>70626-105-13</NDCCode>
<PackageDescription>100 mL in 1 TUBE (70626-105-13) </PackageDescription>
<NDC11Code>70626-0105-13</NDC11Code>
<ProductNDC>70626-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Start So Fresh</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>ASPIRE BRANDS INC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACNE TREATMENT TO HELP CLEAR UP AND PREVENT NEW ACNE BLEMISHES, BLACKHEADS, AND WHITEHEADS.</IndicationAndUsage>
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<NDC>
<NDCCode>70626-105-15</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (70626-105-15) > 15 mL in 1 TUBE</PackageDescription>
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<ProductNDC>70626-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Start So Fresh</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>ASPIRE BRANDS INC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>10889-105-13</NDCCode>
<PackageDescription>1 STICK in 1 APPLICATOR (10889-105-13)</PackageDescription>
<NDC11Code>10889-0105-13</NDC11Code>
<ProductNDC>10889-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Walgreens Original</ProprietaryName>
<ProprietaryNameSuffix>Antiperspirant Deodorant 2.7 Oz</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20080404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>VVF Kansas Services LLC</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For odor protection. Reduces underarm wetness. Turn dial to raise product. Remove plastic dome. Apply a thin even layer to underarms for maximum effectiveness. Do not over apply.</IndicationAndUsage>
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<NDC>
<NDCCode>13537-105-14</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-105-14) > 4 g in 1 TUBE (13537-105-13)</PackageDescription>
<NDC11Code>13537-0105-14</NDC11Code>
<ProductNDC>13537-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Couleur Luxe Rouge Irresistible Maximum Hydration Spf 17</ProprietaryName>
<ProprietaryNameSuffix>(fuchsia Intense) - Purple</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.071; .016</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn. .</IndicationAndUsage>
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<NDC>
<NDCCode>51414-105-13</NDCCode>
<PackageDescription>250 g in 1 BOTTLE (51414-105-13) </PackageDescription>
<NDC11Code>51414-0105-13</NDC11Code>
<ProductNDC>51414-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mouthwash</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20160110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Yuyao Jessie Commodity Co.,Ltd.</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps control plaque that leads to gingivitis and bleeding gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52536-105-13</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (52536-105-13) </PackageDescription>
<NDC11Code>52536-0105-13</NDC11Code>
<ProductNDC>52536-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Erythromycin</ProprietaryName>
<NonProprietaryName>Erythromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061621</ApplicationNumber>
<LabelerName>Wilshire Pharmaceuticals</LabelerName>
<SubstanceName>ERYTHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Tablets, USP and other antibacterial drugs, Erythromycin Tablets, 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. Erythromycin Tablets, USP are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae. Listeriosis caused by Listeria monocytogenes. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin Lactobionate- I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.3. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.3. Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.</IndicationAndUsage>
<Description>Erythromycin Tablets, USP are an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin Tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base. Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>57664-105-13</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (57664-105-13)</PackageDescription>
<NDC11Code>57664-0105-13</NDC11Code>
<ProductNDC>57664-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Salsalate</ProprietaryName>
<NonProprietaryName>Salsalate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>SALSALATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.</IndicationAndUsage>
<Description>Salsalate, is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, salsalate (salicylsalicylic acid or 2-hydroxy-benzoic acid, 2- carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below. Each tablet, for oral administration contains 500 mg or 750 mg of salsalate, USP. In addition each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Povidone, and Stearic Acid. Also contains: Hydroxypropyl Methylcellulose, Polydextrose, Titanium Dioxide, Triacetin, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and Polyethylene Glycol.</Description>
</NDC>
<NDC>
<NDCCode>64709-105-10</NDCCode>
<PackageDescription>.13 g in 1 PACKET (64709-105-10) </PackageDescription>
<NDC11Code>64709-0105-10</NDC11Code>
<ProductNDC>64709-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Wipe</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride Wipe</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Diamond Wipes International</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>13</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ for hand sanitizing to decrease bacteria on skin when water and soap are not available. ■ recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67492-105-13</NDCCode>
<PackageDescription>25.5 g in 1 JAR (67492-105-13) </PackageDescription>
<NDC11Code>67492-0105-13</NDC11Code>
<ProductNDC>67492-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Resinol</ProprietaryName>
<NonProprietaryName>Petrolatum And Resorcinol</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20020629</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>ResiCal, Inc.</LabelerName>
<SubstanceName>PETROLATUM; RESORCINOL</SubstanceName>
<StrengthNumber>55; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20020629</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily protects minor cutsscrapesburns. temporarily relieves pain and itching associated with minor skin irritationsminor burnssunburnminor cutsscrapesinsect bitesrashes due to poison ivy, oak, and sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69452-105-13</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (69452-105-13) </PackageDescription>
<NDC11Code>69452-0105-13</NDC11Code>
<ProductNDC>69452-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Montelukast</ProprietaryName>
<NonProprietaryName>Montelukast</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202859</ApplicationNumber>
<LabelerName>Bionpharma Inc.</LabelerName>
<SubstanceName>MONTELUKAST SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141201</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76891-105-13</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (76891-105-13) </PackageDescription>
<NDC11Code>76891-0105-13</NDC11Code>
<ProductNDC>76891-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Born Basic. Anti-bac Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>65 Percent</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191017</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SCENT THEORY PRODUCTS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DECREASES BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE . RECOMMENDED FOR REPEATED USE.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82393-105-13</NDCCode>
<PackageDescription>5 kg in 1 DRUM (82393-105-13) </PackageDescription>
<NDC11Code>82393-0105-13</NDC11Code>
<ProductNDC>82393-105</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pregnenolone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20211209</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Pharma Source Direct, Inc.</LabelerName>
<SubstanceName>PREGNENOLONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-08</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>09-DEC-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>83589-105-13</NDCCode>
<PackageDescription>250 g in 1 BAG (83589-105-13) </PackageDescription>
<NDC11Code>83589-0105-13</NDC11Code>
<ProductNDC>83589-105</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cjc-1295</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250430</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>CJC-1295</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-APR-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84369-105-01</NDCCode>
<PackageDescription>13 g in 1 BOX (84369-105-01) </PackageDescription>
<NDC11Code>84369-0105-01</NDC11Code>
<ProductNDC>84369-105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Skin Tag Patches</ProprietaryName>
<NonProprietaryName>Skin Tag Patches</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240827</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M028</ApplicationNumber>
<LabelerName>Shenzhen Rongxing Trading Co., Ltd.</LabelerName>
<SubstanceName>HAMAMELIS VIRGINIANA TOP WATER</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For external use only. Avoid direct contact with eyes. Discontinue use if irritation occur. Keep out of reach of childeren. Store in a cool and dry place.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84502-105-13</NDCCode>
<PackageDescription>500 g in 1 BOTTLE (84502-105-13) </PackageDescription>
<NDC11Code>84502-0105-13</NDC11Code>
<ProductNDC>84502-105</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Retatrutide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20250307</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Fujian Genohope Biotech Ltd.</LabelerName>
<SubstanceName>RETATRUTIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-MAR-25</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>84789-105-13</NDCCode>
<PackageDescription>50 g in 1 BAG (84789-105-13) </PackageDescription>
<NDC11Code>84789-0105-13</NDC11Code>
<ProductNDC>84789-105</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cjc-1295</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20240929</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Hangzhou XinHan Biopharma Co., Ltd.</LabelerName>
<SubstanceName>CJC-1295</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-SEP-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0054-0449-49</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00054-0449-49</NDC11Code>
<ProductNDC>0054-0449</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Posaconazole</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208773</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: : 1 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in adults and pediatric patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. (1.2) , 2 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients aged 13 years and older. (1.3).</IndicationAndUsage>
<Description>Posaconazole is an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5-(2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white to off-white powder that is practically insoluble in water. Posaconazole oral suspension is a white to off-white, cherry-brandy flavored immediate-release suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: cherry-brandy flavor, citric acid monohydrate, hydroxyethyl cellulose, glycerin, polyoxyl 35 castor oil, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, titanium dioxide, and water.</Description>
</NDC>
<NDC>
<NDCCode>0085-1328-01</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0085-1328-01) / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00085-1328-01</NDC11Code>
<ProductNDC>0085-1328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Noxafil</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022003</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Noxafil is an azole antifungal indicated as follows: 1 Noxafil is indicated for the treatment of invasive aspergillosis as follows: (1.1) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greaterNoxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg, 2 Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater.Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgNoxafil oral suspension: adults and pediatric patients 13 years of age and olderNoxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg.</IndicationAndUsage>
<Description>Noxafil and Noxafil PowderMix contain posaconazole, an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Noxafil (posaconazole) Injection. Noxafil injection, for intravenous use, is a clear colorless to yellow, without preservatives sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6, and water for injection. Noxafil (posaconazole) Delayed-Release Tablets. Noxafil delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the following inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Noxafil (posaconazole) Oral Suspension. Noxafil oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum. Noxafil PowderMix (posaconazole) for Delayed-Release Oral Suspension. Noxafil PowderMix for delayed-release oral suspension is supplied as a component of a kit. Each kit contains Noxafil as an off-white to yellowish powder for delayed-release oral suspension, a bottle of mixing liquid, two 3 mL (green) notched tip syringes, two 10 mL (blue) notched tip syringes, two mixing cups, and one bottle adapter for the mixing liquid bottle. : 1 Noxafil PowderMix for delayed-release oral suspension contains 300 mg of posaconazole and the following inactive ingredient: hypromellose acetate succinate., 2 The mixing liquid contains: anhydrous citric acid, antifoam Af emulsion, berry citrus sweet flavor, carboxymethylcellulose sodium, carrageenan calcium sulfate trisodium phosphate, glycerin, methylparaben, microcrystalline cellulose, potassium sorbate, propylparaben, purified water, sodium citrate, sodium phosphate monobasic monohydrate, sodium saccharin, sorbitol solution, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0143-9666-06</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (0143-9666-06) / 200 mL in 1 CONTAINER (0143-9666-01) </PackageDescription>
<NDC11Code>00143-9666-06</NDC11Code>
<ProductNDC>0143-9666</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078764</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0143-9667-06</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (0143-9667-06) / 100 mL in 1 CONTAINER (0143-9667-01) </PackageDescription>
<NDC11Code>00143-9667-06</NDC11Code>
<ProductNDC>0143-9667</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078764</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
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<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
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<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
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<PackageDescription>6 CONTAINER in 1 CARTON (0143-9669-06) / 100 mL in 1 CONTAINER (0143-9669-01) </PackageDescription>
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<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
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<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
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<NDC>
<NDCCode>0143-9899-91</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (0143-9899-91) / 100 mL in 1 VIAL (0143-9899-01) </PackageDescription>
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<ProductNDC>0143-9899</ProductNDC>
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<StartMarketingDate>20050823</StartMarketingDate>
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<ApplicationNumber>ANDA076736</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
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<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole Injection, USP is indicated for the treatment of: : 1 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. , 2 Cryptococcal meningitis. Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
<Description>Fluconazole Injection, USP, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in glass and in plastic containers. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:. Fluconazole is a white crystalline solid which is slightly soluble in water and saline. Fluconazole Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL contains 2 mg of Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of Dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volume of 100 mL is packaged in glass and in plastic containers. Injection volume of 200 mL is packed in plastic containers. The plastic container is fabricated from polypropylene. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., cis-13-docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an authorized additive listed in the 21 CFR 175.105 "Indirect Food Additives". However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers.</Description>
</NDC>
<NDC>
<NDCCode>0254-1016-36</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (0254-1016-36) / 105 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00254-1016-36</NDC11Code>
<ProductNDC>0254-1016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Posaconazole</ProprietaryName>
<NonProprietaryName>Posaconazole</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230329</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022003</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>POSACONAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Posaconazole is an azole antifungal indicated as follows: 1 Posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh greater than 40 kg. (1.1), 2 Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kgPosaconazole oral suspension: adults and pediatric patients 13 years of age and older, 3 Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older. (1.3).</IndicationAndUsage>
<Description>Posaconazole delayed-release tablets and Posaconazole oral suspension contain posaconazole; an azole antifungal agent. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5- (1H-1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is. Posaconazole is a white powder with a low aqueous solubility. Posaconazole Delayed-Release Tablets. Posaconazole delayed-release tablet, for oral use, is yellow, coated, and oblong and contains 100 mg of posaconazole. Each delayed-release tablet contains the inactive ingredients: croscarmellose sodium, hydroxypropylcellulose, hypromellose acetate succinate, iron oxide yellow, Macrogol/PEG 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, silicon dioxide, talc, and titanium dioxide. Posaconazole Oral Suspension. Posaconazole oral suspension is a white, cherry-flavored immediate-release suspension that contains 40 mg of posaconazole per mL and the following inactive ingredients: artificial cherry flavor, citric acid monohydrate, glycerin, liquid glucose, polysorbate 80, purified water, simethicone, sodium benzoate, sodium citrate dihydrate, titanium dioxide, and xanthan gum.</Description>
</NDC>
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<NDCCode>0527-4116-37</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-37) </PackageDescription>
<NDC11Code>00527-4116-37</NDC11Code>
<ProductNDC>0527-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212026</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
</NDC>
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<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-4116-41) </PackageDescription>
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<ProductNDC>0527-4116</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212026</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-13</LastUpdate>
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<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
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<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
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<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
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<LabelerName>Lannett Company, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
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<IndicationAndUsage>Propranolol Hydrochloride Extended-Release Capsules are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol Hydrochloride Extended-Release Capsules are not indicated in the management of hypertensive emergencies.</IndicationAndUsage>
<Description>Propranolol hydrochloride, USP is a synthetic beta-adrenergic receptor-blocking agent chemically described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride, (±)-. Its molecular and structural formulae are. C16H21NO2·HCl. Propranolol hydrochloride, USP is a stable, white, crystalline solid which is readily soluble in water and ethanol. Its molecular weight is 295.80. Propranolol Hydrochloride Extended-Release Capsules, USP are formulated to provide a sustained release of propranolol hydrochloride, USP. Propranolol Hydrochloride Extended-Release Capsules, USP are available as 60 mg, 80 mg, 120 mg, and 160 mg capsules for oral administration. : 1 Each 60 mg capsule contains 60 mg propranolol hydrochloride, USP (equivalent to 52.60 mg of propranolol)., 2 Each 80 mg capsule contains 80 mg propranolol hydrochloride, USP (equivalent to 70.14 mg of propranolol)., 3 Each 120 mg capsule contains 120 mg propranolol hydrochloride, USP (equivalent to 105.21 mg of propranolol)., 4 Each 160 mg capsule contains 160 mg propranolol hydrochloride, USP (equivalent to 140.28 mg of propranolol).</Description>
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