{
"NDC": [
{
"NDCCode": "85742-030-28",
"PackageDescription": "100 mL in 1 BOTTLE (85742-030-28) ",
"NDC11Code": "85742-0030-28",
"ProductNDC": "85742-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20221121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216212",
"LabelerName": "Kanchan Healthcare Inc",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221121",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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). 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 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. Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the 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. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. 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. Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days. Prevention of Recurrent Attacks of Rheumatic Fever Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of Streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyceserythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL. Banana flavor, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum."
},
{
"NDCCode": "85742-029-28",
"PackageDescription": "100 mL in 1 BOTTLE (85742-029-28) ",
"NDC11Code": "85742-0029-28",
"ProductNDC": "85742-029",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Erythromycin Ethylsuccinate",
"NonProprietaryName": "Erythromycin Ethylsuccinate",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20221121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216212",
"LabelerName": "Kanchan Healthcare Inc",
"SubstanceName": "ERYTHROMYCIN ETHYLSUCCINATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221121",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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). 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 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. Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the 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. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. 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. Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days. Prevention of Recurrent Attacks of Rheumatic Fever Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of Streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.",
"Description": "Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyceserythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL. Banana flavor, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum."
},
{
"NDCCode": "11673-030-64",
"PackageDescription": "1 TUBE in 1 CARTON (11673-030-64) > 28 g in 1 TUBE",
"NDC11Code": "11673-0030-64",
"ProductNDC": "11673-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Hydrocortisone One Per Cent",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150409",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Target Corporation",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-10-29",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "13537-030-28",
"PackageDescription": "1 TUBE in 1 BOX (13537-030-28) > 4 g in 1 TUBE (13537-030-27)",
"NDC11Code": "13537-0030-28",
"ProductNDC": "13537-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hd Color High Definition Color Spf 20",
"ProprietaryNameSuffix": "(hd Frambuesa Encanto) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140403",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".068",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "24909-030-28",
"PackageDescription": "28 g in 1 TUBE (24909-030-28) ",
"NDC11Code": "24909-0030-28",
"ProductNDC": "24909-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Infection Protection Wound Care",
"NonProprietaryName": "Allantoin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241120",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects minor cuts, scrapes, and burns. Helps prevent, temporarily protect, and relieve chapped or cracked skin."
},
{
"NDCCode": "37808-030-28",
"PackageDescription": "42 g in 1 CONTAINER (37808-030-28) ",
"NDC11Code": "37808-0030-28",
"ProductNDC": "37808-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb Spf 50 Mineral Sunscreen Stick",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200305",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "H.E.B.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "216",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200305",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "52959-030-28",
"PackageDescription": "28 CAPSULE in 1 BOTTLE (52959-030-28)",
"NDC11Code": "52959-0030-28",
"ProductNDC": "52959-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cephalexin",
"NonProprietaryName": "Cephalexin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065229",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "CEPHALEXIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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.",
"Description": "Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, edible printing ink with black iron oxide, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, gelatin, magnesium stearate, microcrystalline cellulose and titanium dioxide."
},
{
"NDCCode": "54136-030-01",
"PackageDescription": "1 TUBE in 1 BOX (54136-030-01) > 28 g in 1 TUBE",
"NDC11Code": "54136-0030-01",
"ProductNDC": "54136-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acure Mineral Protection Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121125",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Better Planet Brands",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "9; 3",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "54237-030-11",
"PackageDescription": "118.28 mL in 1 BOTTLE, PLASTIC (54237-030-11) ",
"NDC11Code": "54237-0030-11",
"ProductNDC": "54237-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Daieme Cosmetic Co,.Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "for hands disinfection, take out about 2ml of gel, rub it on the skin for 1 minute, it can be dry without washing. Repeated use make a slight sticky feeling, please wash with water."
},
{
"NDCCode": "58518-030-03",
"PackageDescription": "28 g in 1 TUBE (58518-030-03) ",
"NDC11Code": "58518-0030-03",
"ProductNDC": "58518-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pro Formula",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Avasol LLC",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "6; 24.5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn."
},
{
"NDCCode": "59651-030-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "59651-0030-28",
"ProductNDC": "59651-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zumandimine",
"NonProprietaryName": "Drospirenone And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209407",
"LabelerName": "Aurobindo Pharma Limited",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180326",
"SamplePackage": "N",
"IndicationAndUsage": "Zumandimine® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "Zumandimine (drospirenone and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen consisting of 28 tablets that contain the ingredients specified for each tablet below:. The inactive ingredients in the light pink to pink tablets are corn starch, FD&C Red no. 40, lactose monohydrate, magnesium stearate, povidone, talc and vitamin-E. The green inert tablets contain anhydrous lactose, croscarmellose sodium, FD &C Blue No.2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "64406-030-02",
"PackageDescription": "1 CARTON in 1 CARTON (64406-030-02) / 1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "64406-0030-02",
"ProductNDC": "64406-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zurzuvae",
"NonProprietaryName": "Zuranolone",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20231031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217369",
"LabelerName": "Biogen MA Inc.",
"SubstanceName": "ZURANOLONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231031",
"SamplePackage": "N",
"IndicationAndUsage": "ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.",
"Description": "ZURZUVAE contains zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator. The chemical name is 1-[(3α, 5β)-3-hydroxy-3-methyl-20- oxo-19-norpregnan-21-yl]-1H-pyrazole-4-carbonitrile and it has the following chemical structure:. The molecular formula of zuranolone is C25H35N3O2 and the relative molecular mass is 409.57 Da. Zuranolone is a white to off-white, non-hygroscopic, crystalline solid. It is sparingly soluble in ethyl acetate, methanol, and ethanol; slightly soluble in methyl tert-butyl ether and isopropanol; soluble in tetrahydrofuran and acetone; and practically insoluble in water and n-heptane. ZURZUVAE is available in 20 mg, 25 mg, and 30 mg capsules for oral administration. Each capsule contains zuranolone as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The capsule shells contain gelatin, red iron oxide, titanium dioxide, and yellow iron oxide, and are imprinted with black ink (containing ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze)."
},
{
"NDCCode": "69396-030-01",
"PackageDescription": "1 TUBE in 1 BOX (69396-030-01) / 28.4 g in 1 TUBE",
"NDC11Code": "69396-0030-01",
"ProductNDC": "69396-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tripleantibioticointmentandpainrelief",
"NonProprietaryName": "Bacitracin,neomycin,polymxin, Pramoxine",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Trifecta Pharmaceuticals USA",
"SubstanceName": "BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE",
"StrengthNumber": "500; 3.5; 10; 10000",
"StrengthUnit": "[USP'U]/100g; mg/100g; mg/100g; [USP'U]/100g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170720",
"SamplePackage": "N",
"IndicationAndUsage": "First Aid to help prevent infection in minor: 1 Cuts, 2 Scrapes, 3 Burns."
},
{
"NDCCode": "72056-030-01",
"PackageDescription": "1 TUBE in 1 CARTON (72056-030-01) > 28.4 g in 1 TUBE",
"NDC11Code": "72056-0030-01",
"ProductNDC": "72056-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181005",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Syntenza Pharmaceuticals LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181005",
"SamplePackage": "N",
"IndicationAndUsage": "An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Indicated also in the treatment of insect bites, burns and fungal infections.",
"Description": "Salicylic Acid 3% topical ointment contains 30 mg salicylic acid per gram in a base containing: PEG-8, PEG-75, Benzoic acid and Quercus Alba Bark Extract."
},
{
"NDCCode": "72092-030-02",
"PackageDescription": "5 POUCH in 1 CARTON (72092-030-02) > 28 mL in 1 POUCH (72092-030-01) ",
"NDC11Code": "72092-0030-02",
"ProductNDC": "72092-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Propolis Repair Mask",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180102",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Racce Co., Ltd.",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": ".56; .01",
"StrengthUnit": "g/28mL; g/28mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180102",
"SamplePackage": "N"
},
{
"NDCCode": "73265-030-02",
"PackageDescription": "10 POUCH in 1 CARTON (73265-030-02) > 28 mL in 1 POUCH (73265-030-01) ",
"NDC11Code": "73265-0030-02",
"ProductNDC": "73265-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Voye Fresh Up Perfect Moisture Mask V Hyaluron Moisture Ampule",
"NonProprietaryName": "Niacinamide, Adenosine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Golden Street",
"SubstanceName": "NIACINAMIDE; ADENOSINE",
"StrengthNumber": ".56; .01",
"StrengthUnit": "g/28mL; g/28mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses:Helps brighten skin tone.Helps improve wrinkle problem."
},
{
"NDCCode": "75997-030-01",
"PackageDescription": "1 KIT in 1 KIT (75997-030-01) * 28 mL in 1 BOTTLE (75997-027-01) * 28 mL in 1 BOTTLE (75997-028-01) * 28 mL in 1 BOTTLE (75997-029-01)",
"NDC11Code": "75997-0030-01",
"ProductNDC": "75997-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer Gift Set",
"ProprietaryNameSuffix": "3-pack",
"NonProprietaryName": "Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20110706",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Papermates, Inc. DBA Noteworthy",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "79097-030-28",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (79097-030-28) ",
"NDC11Code": "79097-0030-28",
"ProductNDC": "79097-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Personal Performance Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Autotrol Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "81899-030-01",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 BOX (81899-030-01) / 30 mL in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "81899-0030-01",
"ProductNDC": "81899-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunnydays Broad Spectrum Spf 30 Tinted Sunscreen",
"ProprietaryNameSuffix": "30 Pch",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Tower 28",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "126",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210815",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. ."
},
{
"NDCCode": "82293-030-10",
"PackageDescription": "28 TABLET in 1 BOTTLE (82293-030-10) ",
"NDC11Code": "82293-0030-10",
"ProductNDC": "82293-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219955",
"LabelerName": "Novugen Pharma (USA) LLC.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260330",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets are a kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1) , 2 Adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2) , 3 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4) .",
"Description": "Everolimus tablets are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.22 g/mol. The structural formula is:. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus, USP and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, and magnesium stearate."
},
{
"NDCCode": "82442-030-28",
"PackageDescription": "1 TUBE in 1 CARTON (82442-030-28) / 28 g in 1 TUBE",
"NDC11Code": "82442-0030-28",
"ProductNDC": "82442-030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rapid Relief Hemorrhoid",
"NonProprietaryName": "14.4% Glycerin, 0.25% Phenylephrine Hcl, 5% Lidocaine, 15% Petrolatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240815",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "Target Corporation",
"SubstanceName": "GLYCERIN; LIDOCAINE; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "144; 50; 150; 2.5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240815",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful."
},
{
"NDCCode": "85742-015-15",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (85742-015-15) ",
"NDC11Code": "85742-0015-15",
"ProductNDC": "85742-015",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217151",
"LabelerName": "Kanchan Healthcare Inc",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/561",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets is indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg)."
},
{
"NDCCode": "85742-016-15",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (85742-016-15) ",
"NDC11Code": "85742-0016-15",
"ProductNDC": "85742-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217151",
"LabelerName": "Kanchan Healthcare Inc",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/561",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets is indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg)."
},
{
"NDCCode": "85742-016-16",
"PackageDescription": "1 BLISTER PACK in 1 BOX (85742-016-16) / 56 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "85742-0016-16",
"ProductNDC": "85742-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217151",
"LabelerName": "Kanchan Healthcare Inc",
"SubstanceName": "VARENICLINE TARTRATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/561",
"Pharm_Classes": "Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets is indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg)."
},
{
"NDCCode": "85742-017-17",
"PackageDescription": "1 KIT in 1 BOX (85742-017-17) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "85742-0017-17",
"ProductNDC": "85742-017",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline Tartrate",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "KIT",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217151",
"LabelerName": "Kanchan Healthcare Inc",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets is indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg)."
},
{
"NDCCode": "0555-9047-58",
"PackageDescription": "6 POUCH in 1 CARTON (0555-9047-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "00555-9047-58",
"ProductNDC": "0555-9047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enpresse",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20020627",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075809",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020627",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD.",
"Description": "Each Enpresse® (levonorgestrel and ethinyl estradiol tablets USP – triphasic regimen) cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 pink tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 orange tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green inert tablets. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and pregelatinized corn starch. Coloring agents used are as follows: pink, 0.050 mg/0.030 mg tablets: D&C Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white, 0.075 mg/0.040 mg tablets: none; orange, 0.125 mg/0.030 mg tablets: FD&C Yellow No. 6 Aluminum Lake, 38-42%; and light-green, inert tablets: D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Levonorgestrel, USP MW: 312.45 MF: C21H28O2. Ethinyl Estradiol, USP MW: 296.40 MF: C20H24O2."
},
{
"NDCCode": "11086-030-40",
"PackageDescription": "40 g in 1 TUBE (11086-030-40) ",
"NDC11Code": "11086-0030-40",
"ProductNDC": "11086-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Keralyt",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "GEL",
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"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Summers Laboratories Inc",
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"StrengthNumber": "6",
"StrengthUnit": "g/100g",
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"IndicationAndUsage": "INDICATIONS AND USAGE- For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.",
"Description": "DESCRIPTION:KERALYT® is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, SD-40 alcohol (21%), hydroxypropylcellulose and purified water. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:."
},
{
"NDCCode": "16714-340-01",
"PackageDescription": "1 BLISTER PACK in 1 PACKET (16714-340-01) / 1 KIT in 1 BLISTER PACK",
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"ProductNDC": "16714-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Northstar Rx LLC",
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"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Each LEVONEST cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-340-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (16714-340-02) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0340-02",
"ProductNDC": "16714-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonest",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
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"StartMarketingDate": "20101229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090719",
"LabelerName": "Northstar Rx LLC",
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"LastUpdate": "2025-12-16",
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"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Each LEVONEST cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "16714-340-03",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (16714-340-03) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "16714-0340-03",
"ProductNDC": "16714-340",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levonest",
"NonProprietaryName": "Levonorgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20101229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090719",
"LabelerName": "Northstar Rx LLC",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101229",
"SamplePackage": "N",
"IndicationAndUsage": "Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Each LEVONEST cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch."
}
]
}
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<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. 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. 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). 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 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. Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the 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. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. 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. Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days. Prevention of Recurrent Attacks of Rheumatic Fever Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of Streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).1.</IndicationAndUsage>
<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyceserythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL. Banana flavor, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum.</Description>
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<Description>Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyceserythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol. Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.06. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL. Banana flavor, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum.</Description>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects minor cuts, scrapes, and burns. Helps prevent, temporarily protect, and relieve chapped or cracked skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37808-030-28</NDCCode>
<PackageDescription>42 g in 1 CONTAINER (37808-030-28) </PackageDescription>
<NDC11Code>37808-0030-28</NDC11Code>
<ProductNDC>37808-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heb Spf 50 Mineral Sunscreen Stick</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200305</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>H.E.B.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>216</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52959-030-28</NDCCode>
<PackageDescription>28 CAPSULE in 1 BOTTLE (52959-030-28)</PackageDescription>
<NDC11Code>52959-0030-28</NDC11Code>
<ProductNDC>52959-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cephalexin</ProprietaryName>
<NonProprietaryName>Cephalexin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065229</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>CEPHALEXIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes. (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.). Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis. Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes. Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis. Genitourinary tract infections, including acute prostatitis, caused by Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cephalexin capsules and other antibacterial drugs, cephalexin capsules 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.</IndicationAndUsage>
<Description>Cephalexin, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7- (D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C16H17N3O4S H2O and the molecular weight is 365.41. Cephalexin has the following structural formula. The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e., the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1 or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. Each capsule contains cephalexin USP equivalent to 250 mg or 500 mg of anhydrous cephalexin. The capsules also contain the following inactive ingredients D&C Yellow 10, edible printing ink with black iron oxide, FD&C Blue 1, FD&C Green 3, FD&C Yellow 6, gelatin, magnesium stearate, microcrystalline cellulose and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>54136-030-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (54136-030-01) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>54136-0030-01</NDC11Code>
<ProductNDC>54136-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acure Mineral Protection Sunscreen Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Better Planet Brands</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>9; 3</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54237-030-11</NDCCode>
<PackageDescription>118.28 mL in 1 BOTTLE, PLASTIC (54237-030-11) </PackageDescription>
<NDC11Code>54237-0030-11</NDC11Code>
<ProductNDC>54237-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Daieme Cosmetic Co,.Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for hands disinfection, take out about 2ml of gel, rub it on the skin for 1 minute, it can be dry without washing. Repeated use make a slight sticky feeling, please wash with water.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58518-030-03</NDCCode>
<PackageDescription>28 g in 1 TUBE (58518-030-03) </PackageDescription>
<NDC11Code>58518-0030-03</NDC11Code>
<ProductNDC>58518-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pro Formula</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Avasol LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>6; 24.5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59651-030-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59651-0030-28</NDC11Code>
<ProductNDC>59651-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zumandimine</ProprietaryName>
<NonProprietaryName>Drospirenone And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209407</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zumandimine® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>Zumandimine (drospirenone and ethinyl estradiol tablets, USP) provide an oral contraceptive regimen consisting of 28 tablets that contain the ingredients specified for each tablet below:. The inactive ingredients in the light pink to pink tablets are corn starch, FD&C Red no. 40, lactose monohydrate, magnesium stearate, povidone, talc and vitamin-E. The green inert tablets contain anhydrous lactose, croscarmellose sodium, FD &C Blue No.2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C24H30O3. Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C20H24O2. The structural formulas are as follows. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>64406-030-02</NDCCode>
<PackageDescription>1 CARTON in 1 CARTON (64406-030-02) / 1 BLISTER PACK in 1 CARTON / 28 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64406-0030-02</NDC11Code>
<ProductNDC>64406-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zurzuvae</ProprietaryName>
<NonProprietaryName>Zuranolone</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217369</ApplicationNumber>
<LabelerName>Biogen MA Inc.</LabelerName>
<SubstanceName>ZURANOLONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Receptor Positive Modulators [MoA], Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults.</IndicationAndUsage>
<Description>ZURZUVAE contains zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator. The chemical name is 1-[(3α, 5β)-3-hydroxy-3-methyl-20- oxo-19-norpregnan-21-yl]-1H-pyrazole-4-carbonitrile and it has the following chemical structure:. The molecular formula of zuranolone is C25H35N3O2 and the relative molecular mass is 409.57 Da. Zuranolone is a white to off-white, non-hygroscopic, crystalline solid. It is sparingly soluble in ethyl acetate, methanol, and ethanol; slightly soluble in methyl tert-butyl ether and isopropanol; soluble in tetrahydrofuran and acetone; and practically insoluble in water and n-heptane. ZURZUVAE is available in 20 mg, 25 mg, and 30 mg capsules for oral administration. Each capsule contains zuranolone as the active ingredient and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The capsule shells contain gelatin, red iron oxide, titanium dioxide, and yellow iron oxide, and are imprinted with black ink (containing ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze).</Description>
</NDC>
<NDC>
<NDCCode>69396-030-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (69396-030-01) / 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>69396-0030-01</NDC11Code>
<ProductNDC>69396-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tripleantibioticointmentandpainrelief</ProprietaryName>
<NonProprietaryName>Bacitracin,neomycin,polymxin, Pramoxine</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Trifecta Pharmaceuticals USA</LabelerName>
<SubstanceName>BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>500; 3.5; 10; 10000</StrengthNumber>
<StrengthUnit>[USP'U]/100g; mg/100g; mg/100g; [USP'U]/100g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First Aid to help prevent infection in minor: 1 Cuts, 2 Scrapes, 3 Burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72056-030-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72056-030-01) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>72056-0030-01</NDC11Code>
<ProductNDC>72056-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181005</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Syntenza Pharmaceuticals LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Indicated also in the treatment of insect bites, burns and fungal infections.</IndicationAndUsage>
<Description>Salicylic Acid 3% topical ointment contains 30 mg salicylic acid per gram in a base containing: PEG-8, PEG-75, Benzoic acid and Quercus Alba Bark Extract.</Description>
</NDC>
<NDC>
<NDCCode>72092-030-02</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (72092-030-02) > 28 mL in 1 POUCH (72092-030-01) </PackageDescription>
<NDC11Code>72092-0030-02</NDC11Code>
<ProductNDC>72092-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Propolis Repair Mask</ProprietaryName>
<NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Racce Co., Ltd.</LabelerName>
<SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
<StrengthNumber>.56; .01</StrengthNumber>
<StrengthUnit>g/28mL; g/28mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>73265-030-02</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (73265-030-02) > 28 mL in 1 POUCH (73265-030-01) </PackageDescription>
<NDC11Code>73265-0030-02</NDC11Code>
<ProductNDC>73265-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Voye Fresh Up Perfect Moisture Mask V Hyaluron Moisture Ampule</ProprietaryName>
<NonProprietaryName>Niacinamide, Adenosine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Golden Street</LabelerName>
<SubstanceName>NIACINAMIDE; ADENOSINE</SubstanceName>
<StrengthNumber>.56; .01</StrengthNumber>
<StrengthUnit>g/28mL; g/28mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses:Helps brighten skin tone.Helps improve wrinkle problem.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75997-030-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (75997-030-01) * 28 mL in 1 BOTTLE (75997-027-01) * 28 mL in 1 BOTTLE (75997-028-01) * 28 mL in 1 BOTTLE (75997-029-01)</PackageDescription>
<NDC11Code>75997-0030-01</NDC11Code>
<ProductNDC>75997-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer Gift Set</ProprietaryName>
<ProprietaryNameSuffix>3-pack</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110706</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Papermates, Inc. DBA Noteworthy</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>79097-030-28</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (79097-030-28) </PackageDescription>
<NDC11Code>79097-0030-28</NDC11Code>
<ProductNDC>79097-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Personal Performance Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Autotrol Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81899-030-01</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 BOX (81899-030-01) / 30 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>81899-0030-01</NDC11Code>
<ProductNDC>81899-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunnydays Broad Spectrum Spf 30 Tinted Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>30 Pch</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Tower 28</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>126</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>82293-030-10</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (82293-030-10) </PackageDescription>
<NDC11Code>82293-0030-10</NDC11Code>
<ProductNDC>82293-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219955</ApplicationNumber>
<LabelerName>Novugen Pharma (USA) LLC.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets are a kinase inhibitor indicated for the treatment of: 1 Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1) , 2 Adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: Everolimus tablets are not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2) , 3 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4) .</IndicationAndUsage>
<Description>Everolimus tablets are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.22 g/mol. The structural formula is:. Everolimus tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus, USP and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>82442-030-28</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (82442-030-28) / 28 g in 1 TUBE</PackageDescription>
<NDC11Code>82442-0030-28</NDC11Code>
<ProductNDC>82442-030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rapid Relief Hemorrhoid</ProprietaryName>
<NonProprietaryName>14.4% Glycerin, 0.25% Phenylephrine Hcl, 5% Lidocaine, 15% Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>GLYCERIN; LIDOCAINE; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>144; 50; 150; 2.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of pain, soreness and burning. helps relieve the local itching and discomfort associated with hemorrhoids. temporarily shrinks hemorrhoidal tissue. temporarily provides a coating for relief of anorectal discomforts. temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>85742-015-15</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (85742-015-15) </PackageDescription>
<NDC11Code>85742-0015-15</NDC11Code>
<ProductNDC>85742-015</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217151</ApplicationNumber>
<LabelerName>Kanchan Healthcare Inc</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/561</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg).</Description>
</NDC>
<NDC>
<NDCCode>85742-016-15</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (85742-016-15) </PackageDescription>
<NDC11Code>85742-0016-15</NDC11Code>
<ProductNDC>85742-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217151</ApplicationNumber>
<LabelerName>Kanchan Healthcare Inc</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/561</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg).</Description>
</NDC>
<NDC>
<NDCCode>85742-016-16</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (85742-016-16) / 56 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>85742-0016-16</NDC11Code>
<ProductNDC>85742-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217151</ApplicationNumber>
<LabelerName>Kanchan Healthcare Inc</LabelerName>
<SubstanceName>VARENICLINE TARTRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/561</StrengthUnit>
<Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg).</Description>
</NDC>
<NDC>
<NDCCode>85742-017-17</NDCCode>
<PackageDescription>1 KIT in 1 BOX (85742-017-17) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>85742-0017-17</NDC11Code>
<ProductNDC>85742-017</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline Tartrate</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217151</ApplicationNumber>
<LabelerName>Kanchan Healthcare Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets is indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is:. Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg).</Description>
</NDC>
<NDC>
<NDCCode>0555-9047-58</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0555-9047-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00555-9047-58</NDC11Code>
<ProductNDC>0555-9047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enpresse</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20020627</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075809</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020627</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD.</IndicationAndUsage>
<Description>Each Enpresse® (levonorgestrel and ethinyl estradiol tablets USP – triphasic regimen) cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 pink tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 orange tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green inert tablets. The inactive ingredients present are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and pregelatinized corn starch. Coloring agents used are as follows: pink, 0.050 mg/0.030 mg tablets: D&C Yellow No. 10 Aluminum Lake and D&C Red No. 7 Calcium Lake; white, 0.075 mg/0.040 mg tablets: none; orange, 0.125 mg/0.030 mg tablets: FD&C Yellow No. 6 Aluminum Lake, 38-42%; and light-green, inert tablets: D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Levonorgestrel, USP MW: 312.45 MF: C21H28O2. Ethinyl Estradiol, USP MW: 296.40 MF: C20H24O2.</Description>
</NDC>
<NDC>
<NDCCode>11086-030-40</NDCCode>
<PackageDescription>40 g in 1 TUBE (11086-030-40) </PackageDescription>
<NDC11Code>11086-0030-40</NDC11Code>
<ProductNDC>11086-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Keralyt</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Summers Laboratories Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-03-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20091101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INDICATIONS AND USAGE- For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses.</IndicationAndUsage>
<Description>DESCRIPTION:KERALYT® is a gel for topical administration containing salicylic acid 6%, in a vehicle composed of propylene glycol, SD-40 alcohol (21%), hydroxypropylcellulose and purified water. Salicylic acid is the 2 hydroxy derivative of benzoic acid having the following structure:.</Description>
</NDC>
<NDC>
<NDCCode>16714-340-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKET (16714-340-01) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0340-01</NDC11Code>
<ProductNDC>16714-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonest</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090719</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Each LEVONEST cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-340-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (16714-340-02) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0340-02</NDC11Code>
<ProductNDC>16714-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonest</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090719</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Each LEVONEST cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>16714-340-03</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (16714-340-03) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>16714-0340-03</NDC11Code>
<ProductNDC>16714-340</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levonest</ProprietaryName>
<NonProprietaryName>Levonorgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20101229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090719</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Each LEVONEST cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 yellow tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); phase 2 comprised of 5 green tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light brown tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 white inert tablets. The inactive ingredients present in the yellow, green and light brown tablets are lactose, magnesium stearate and pregelatinized corn starch. Each yellow tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each green tablet also contains FD&C Yellow #5 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, titanium dioxide, macrogol/ polyethylene glycol 3000 NF, lecithin (soya), talc, and polyvinyl alcohol. Each light brown tablet also contains iron oxide yellow, iron oxide red, iron oxide black, titanium dioxide, macrogol/ polyethylene glycol 3350 NF, lecithin (soya), talc, and polyvinyl alcohol. Each inactive, white tablet (7) contains the following inactive ingredients: Titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
</NDCList>