{
"NDC": [
{
"NDCCode": "55111-799-12",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55111-799-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-12",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-799-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55111-799-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-24",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-799-36",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (55111-799-36) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-36",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-799-84",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (55111-799-84) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-84",
"ProductNDC": "55111-799",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-DEC-17"
},
{
"NDCCode": "55111-799-04",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (55111-799-04) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) ",
"NDC11Code": "55111-0799-04",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "49035-606-12",
"PackageDescription": "1 KIT in 1 KIT (49035-606-12) * 1 BOTTLE in 1 CARTON (49035-799-26) > 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE",
"NDC11Code": "49035-0606-12",
"ProductNDC": "49035-606",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Adult Tussin Dm Max Daytime Nighttime",
"NonProprietaryName": "Dextromethorphan Hbr, Doxylamine Succinate, Guaifenesin",
"DosageFormName": "KIT",
"StartMarketingDate": "20170721",
"EndMarketingDate": "20210314",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Wal-Mart Stores Inc",
"Status": "Deprecated",
"LastUpdate": "2021-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170721",
"EndMarketingDatePackage": "20210314",
"SamplePackage": "N"
},
{
"NDCCode": "51316-799-08",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (51316-799-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "51316-0799-08",
"ProductNDC": "51316-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260127",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260127",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
},
{
"NDCCode": "54766-799-65",
"PackageDescription": "12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-65) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) ",
"NDC11Code": "54766-0799-65",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150807",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "54766-799-72",
"PackageDescription": "12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-72) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-33) ",
"NDC11Code": "54766-0799-72",
"ProductNDC": "54766-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Analpram Hc",
"NonProprietaryName": "Hydrocortisone Acetate And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150807",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sebela Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20150807",
"SamplePackage": "N",
"IndicationAndUsage": "INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87."
},
{
"NDCCode": "63482-799-12",
"PackageDescription": "10 kg in 1 DRUM (63482-799-12) ",
"NDC11Code": "63482-0799-12",
"ProductNDC": "63482-799",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oseltamivir Phosphate",
"DosageFormName": "POWDER",
"StartMarketingDate": "19991027",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "PATHEON API, INC",
"SubstanceName": "OSELTAMIVIR PHOSPHATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-02-10",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "27-OCT-99"
},
{
"NDCCode": "69842-799-12",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (69842-799-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "69842-0799-12",
"ProductNDC": "69842-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bismuth Subsalicylate",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200709",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "CVS PHARMACY, INC.",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "262",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200709",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers' diarrhea , 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching, 4 fullness."
},
{
"NDCCode": "55111-118-12",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55111-118-12) / 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "55111-0118-12",
"ProductNDC": "55111-118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077367",
"LabelerName": "Dr.Reddys Laboratories Limited",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060930",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages."
},
{
"NDCCode": "55111-145-12",
"PackageDescription": "12 DOSE PACK in 1 CARTON (55111-145-12) / 1 TABLET in 1 DOSE PACK (55111-145-71) ",
"NDC11Code": "55111-0145-12",
"ProductNDC": "55111-145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076658",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140620",
"SamplePackage": "N",
"IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.",
"Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-158-34",
"PackageDescription": "12 BOTTLE in 1 CARTON (55111-158-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "55111-0158-34",
"ProductNDC": "55111-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160428",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-645-34",
"PackageDescription": "12 BOTTLE in 1 CARTON (55111-645-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "55111-0645-34",
"ProductNDC": "55111-645",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078490",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150514",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells have the following inactive ingredients: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-693-12",
"PackageDescription": "2 SYRINGE in 1 CARTON (55111-693-12) > .5 mL in 1 SYRINGE (55111-693-05) ",
"NDC11Code": "55111-0693-12",
"ProductNDC": "55111-693",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20140224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090495",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140224",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: 1 Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. , 2 Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.",
"Description": "Sumatriptan injection USP contains sumatriptan succinate, USP a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate, USP is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder and is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Sumatriptan injection USP is a clear, colorless to pale yellow, free from visible particulate matter, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection solution contains 8.4 mg of sumatriptan succinate, USP equivalent to 6 mg of sumatriptan, USP and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solutions is approximately 4.2 to 5.3. The osmolality of the injection is between 275 and 315 mOsm/kg."
},
{
"NDCCode": "55111-739-48",
"PackageDescription": "12 POUCH in 1 CASE (55111-739-48) / 4000 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-739-94) ",
"NDC11Code": "55111-0739-48",
"ProductNDC": "55111-739",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"StartMarketingDate": "20120518",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-07-10",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "18-MAY-22"
},
{
"NDCCode": "21130-799-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-799-34) > 237 mL in 1 BOTTLE",
"NDC11Code": "21130-0799-34",
"ProductNDC": "21130-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Tussin",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20150812",
"EndMarketingDate": "20211217",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Safeway",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/10mL; mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150812",
"EndMarketingDatePackage": "20211217",
"SamplePackage": "N"
},
{
"NDCCode": "23155-799-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-799-01) ",
"NDC11Code": "23155-0799-01",
"ProductNDC": "23155-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perphenazine",
"NonProprietaryName": "Perphenazine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210163",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "PERPHENAZINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2024-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221001",
"SamplePackage": "N",
"IndicationAndUsage": "Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.",
"Description": "Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol),a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2mg, 4mg, 8mg, and 16 mg of perphenazine. Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80 and titanium dioxide. Its structural formula is. ACTIONS. Perphenazine has actions at all levels of the central nervous system, particularly the hypothalamus. However, the site and mechanism of action of therapeutic effect are not known."
},
{
"NDCCode": "37808-799-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (37808-799-26) > 118 mL in 1 BOTTLE",
"NDC11Code": "37808-0799-26",
"ProductNDC": "37808-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Cough And Chest Congestion Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "H E B",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/10mL; mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160411",
"SamplePackage": "N"
},
{
"NDCCode": "37808-799-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (37808-799-34) > 237 mL in 1 BOTTLE",
"NDC11Code": "37808-0799-34",
"ProductNDC": "37808-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tussin Cough And Chest Congestion Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "H E B",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 400",
"StrengthUnit": "mg/10mL; mg/10mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160411",
"SamplePackage": "N"
},
{
"NDCCode": "42806-799-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42806-799-01) ",
"NDC11Code": "42806-0799-01",
"ProductNDC": "42806-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "42806-799-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (42806-799-05) ",
"NDC11Code": "42806-0799-05",
"ProductNDC": "42806-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "42806-799-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42806-799-30) ",
"NDC11Code": "42806-0799-30",
"ProductNDC": "42806-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "42806-799-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (42806-799-60) ",
"NDC11Code": "42806-0799-60",
"ProductNDC": "42806-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rifampin",
"NonProprietaryName": "Rifampin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064150",
"LabelerName": "EPIC PHARMA, LLC",
"SubstanceName": "RIFAMPIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211215",
"SamplePackage": "N",
"IndicationAndUsage": "In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.",
"Description": "Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28."
},
{
"NDCCode": "43269-799-24",
"PackageDescription": "709 mL in 1 BOTTLE, PUMP (43269-799-24)",
"NDC11Code": "43269-0799-24",
"ProductNDC": "43269-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orange Blossom Antibacterial Foaming Hand Wash",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "SJ Creations, Inc.",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": ".2",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-12-13",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "46708-799-31",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (46708-799-31) ",
"NDC11Code": "46708-0799-31",
"ProductNDC": "46708-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa And Entacapone",
"NonProprietaryName": "Carbidopa, Levodopa And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218535",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "CARBIDOPA; LEVODOPA; ENTACAPONE",
"StrengthNumber": "37.5; 150; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260212",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
"Description": "Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa, Levodopa And Entacapone",
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"IndicationAndUsage": "Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.",
"Description": "Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide."
},
{
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Hemorrhoidal",
"NonProprietaryName": "Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum",
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"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "McKesson",
"SubstanceName": "GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM",
"StrengthNumber": "14.4; .25; 1; 15",
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},
{
"NDCCode": "49349-799-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (49349-799-02)",
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"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
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"StartMarketingDate": "20111031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
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}
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}
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-02</LastUpdate>
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<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny noseitchy, watery eyessneezingitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
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<PackageDescription>12 TUBE, WITH APPLICATOR in 1 CARTON (54766-799-65) / 4 g in 1 TUBE, WITH APPLICATOR (54766-799-36) </PackageDescription>
<NDC11Code>54766-0799-65</NDC11Code>
<ProductNDC>54766-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Analpram Hc</ProprietaryName>
<NonProprietaryName>Hydrocortisone Acetate And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150807</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
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<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
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<ProprietaryName>Analpram Hc</ProprietaryName>
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<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sebela Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>INIDCATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>DESCRIPTION: Analpram HC® Cream 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrolipid base containing stearic acid, cetyl alcohol, Aquaphor ®, isopropyl palmitate, polyoxyl 40 stearate, propylene glycol, potassium sorbate, sorbic acid, triethanolamine lauryl sulfate, and purified water. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below. hydrocortisone acetate Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)- C 23H 32O 6; mol. wt.: 404.50. pramoxine hydrochloride 4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride C 17H 27NO 3.HCl; mol. wt.: 329.87.</Description>
</NDC>
<NDC>
<NDCCode>63482-799-12</NDCCode>
<PackageDescription>10 kg in 1 DRUM (63482-799-12) </PackageDescription>
<NDC11Code>63482-0799-12</NDC11Code>
<ProductNDC>63482-799</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oseltamivir Phosphate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19991027</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>PATHEON API, INC</LabelerName>
<SubstanceName>OSELTAMIVIR PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-02-10</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>27-OCT-99</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>69842-799-12</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (69842-799-12) / 12 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>69842-0799-12</NDC11Code>
<ProductNDC>69842-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bismuth Subsalicylate</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>CVS PHARMACY, INC.</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>262</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers' diarrhea , 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including: heartburn, indigestion, nausea, gas, belching, 4 fullness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-118-12</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (55111-118-12) / 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0118-12</NDC11Code>
<ProductNDC>55111-118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077367</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Limited</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach. prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-145-12</NDCCode>
<PackageDescription>12 DOSE PACK in 1 CARTON (55111-145-12) / 1 TABLET in 1 DOSE PACK (55111-145-71) </PackageDescription>
<NDC11Code>55111-0145-12</NDC11Code>
<ProductNDC>55111-145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076658</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluconazole tablets are indicated for the treatment of:. 1. Vaginal candidiasis (vaginal yeast infections due to Candida). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.</IndicationAndUsage>
<Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with a molecular formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is. Fluconazole, USP is a white or almost white crystalline powder, which is freely soluble in methanol, soluble in alcohol and in acetone, sparingly soluble in isopropyl alcohol and in chloroform. Slightly soluble in water, very slightly soluble in toluene. Fluconazole tablets, USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole, USP and the following inactive ingredients: dibasic calcium phosphate anhydrous, ferric oxide (iron oxide, red), magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch. Fluconazole tablets meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-158-34</NDCCode>
<PackageDescription>12 BOTTLE in 1 CARTON (55111-158-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0158-34</NDC11Code>
<ProductNDC>55111-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090121</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsule, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-645-34</NDCCode>
<PackageDescription>12 BOTTLE in 1 CARTON (55111-645-34) / 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>55111-0645-34</NDC11Code>
<ProductNDC>55111-645</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078490</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsules, USP is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole USP is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole USP is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hypromellose (5cps), meglumine, methacrylic acid copolymer, poloxamer, sugar globules, talc, titanium dioxide, and triethyl citrate. The capsule shells have the following inactive ingredients: black iron oxide, D & C Red 28, FD & C Blue 1, FD & C Red 40, gelatin, potassium hydroxide, propylene glycol, shellac, titanium dioxide, and yellow iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-693-12</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (55111-693-12) > .5 mL in 1 SYRINGE (55111-693-05) </PackageDescription>
<NDC11Code>55111-0693-12</NDC11Code>
<ProductNDC>55111-693</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20140224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090495</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: 1 Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. , 2 Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.</IndicationAndUsage>
<Description>Sumatriptan injection USP contains sumatriptan succinate, USP a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate, USP is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder and is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Sumatriptan injection USP is a clear, colorless to pale yellow, free from visible particulate matter, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection solution contains 8.4 mg of sumatriptan succinate, USP equivalent to 6 mg of sumatriptan, USP and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solutions is approximately 4.2 to 5.3. The osmolality of the injection is between 275 and 315 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>55111-739-48</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (55111-739-48) / 4000 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-739-94) </PackageDescription>
<NDC11Code>55111-0739-48</NDC11Code>
<ProductNDC>55111-739</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<StartMarketingDate>20120518</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-07-10</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-MAY-22</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>21130-799-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-799-34) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0799-34</NDC11Code>
<ProductNDC>21130-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Tussin</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150812</StartMarketingDate>
<EndMarketingDate>20211217</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150812</StartMarketingDatePackage>
<EndMarketingDatePackage>20211217</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-799-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (23155-799-01) </PackageDescription>
<NDC11Code>23155-0799-01</NDC11Code>
<ProductNDC>23155-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perphenazine</ProprietaryName>
<NonProprietaryName>Perphenazine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210163</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PERPHENAZINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation.</IndicationAndUsage>
<Description>Perphenazine (4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol),a piperazinyl phenothiazine, having the chemical formula, C21H26CIN3OS. It is available as oral tablets containing 2mg, 4mg, 8mg, and 16 mg of perphenazine. Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polysorbate 80 and titanium dioxide. Its structural formula is. ACTIONS. Perphenazine has actions at all levels of the central nervous system, particularly the hypothalamus. However, the site and mechanism of action of therapeutic effect are not known.</Description>
</NDC>
<NDC>
<NDCCode>37808-799-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37808-799-26) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>37808-0799-26</NDC11Code>
<ProductNDC>37808-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Cough And Chest Congestion Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37808-799-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37808-799-34) > 237 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>37808-0799-34</NDC11Code>
<ProductNDC>37808-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tussin Cough And Chest Congestion Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42806-799-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42806-799-01) </PackageDescription>
<NDC11Code>42806-0799-01</NDC11Code>
<ProductNDC>42806-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rifampin</ProprietaryName>
<NonProprietaryName>Rifampin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
<SubstanceName>RIFAMPIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
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<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
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<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
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<LastUpdate>2023-12-23</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064150</ApplicationNumber>
<LabelerName>EPIC PHARMA, LLC</LabelerName>
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<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Bacteriologic cultures should be obtained before the start of therapy to confirm the susceptibility of the organism to rifampin and they should be repeated throughout therapy to monitor the response to treatment. Since resistance can emerge rapidly, susceptibility tests should be performed in the event of persistent positive cultures during the course of treatment. If test results show resistance to rifampin and the patient is not responding to therapy, the drug regimen should be modified.</IndicationAndUsage>
<Description>Rifampin is a semisynthetic antibiotic derivative of rifamycin SV. Rifampin is a red-brown crystalline powder very slightly soluble in water at neutral pH, freely soluble in chloroform, soluble in ethyl acetate and in methanol. Its molecular weight is 822.95 and its chemical formula is C43H58N4O12. The chemical name for rifampin is either: 3-[[(4-methyl-1-piperazinyl) imino]methyl]rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-methyl-1-piperazinyl)formimidoyl]-2,7-(epoxypentadeca[1,11,13] trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. Its structural formula is. Rifampin capsules, USP for oral administration, contain 150 mg or 300 mg rifampin per capsule. The 150 mg and 300 mg capsules also contain the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C Yellow #10 aluminum lake, docusate sodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, propylene glycol, shellac glaze, sodium benzoate, black iron oxide, talc, and titanium dioxide. The 150 mg capsules also contain D&C yellow #10, and D&C Red #28.</Description>
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<NDCCode>43269-799-24</NDCCode>
<PackageDescription>709 mL in 1 BOTTLE, PUMP (43269-799-24)</PackageDescription>
<NDC11Code>43269-0799-24</NDC11Code>
<ProductNDC>43269-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orange Blossom Antibacterial Foaming Hand Wash</ProprietaryName>
<NonProprietaryName>Triclosan</NonProprietaryName>
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<StartMarketingDate>20120801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>SJ Creations, Inc.</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2018-12-13</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (46708-799-31) </PackageDescription>
<NDC11Code>46708-0799-31</NDC11Code>
<ProductNDC>46708-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218535</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
<StrengthNumber>37.5; 150; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide.</Description>
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<ProprietaryName>Carbidopa, Levodopa And Entacapone</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa And Entacapone</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218535</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA; ENTACAPONE</SubstanceName>
<StrengthNumber>37.5; 150; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and entacapone tablets can be used: To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.</IndicationAndUsage>
<Description>Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson’s disease. Carbidopa USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, freely soluble in 3 N hydrochloric acid; slightly soluble in water and in methanol; practically insoluble in alcohol, in acetone, in chloroform and in ether, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is:. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa USP, an aromatic amino acid, is a white to off-white, crystalline powder, slightly soluble in water, freely soluble in 3 N hydrochloric acid and insoluble in alcohol, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is:. Entacapone USP, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Carbidopa, levodopa and entacapone is supplied as tablets in 6 strengths: Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg: 12.5 mg of carbidopa USP, 50 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 18.75 mg/75 mg/200 mg: 18.75 mg of carbidopa USP, 75 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 25 mg/100 mg/200 mg: 25 mg of carbidopa USP, 100 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 31.25 mg/125 mg/200 mg: 31.25 mg of carbidopa USP, 125 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 37.5 mg/150 mg/200 mg: 37.5 mg of carbidopa USP, 150 mg of levodopa USP and 200 mg of entacapone USP. Carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg: 50 mg of carbidopa USP, 200 mg of levodopa USP and 200 mg of entacapone USP. Inactive Ingredients: Mannitol, corn starch, croscarmellose sodium, povidone (K-30), colloidal silicon dioxide, magnesium stearate, hypromellose, glycerin, titanium dioxide, iron oxide red, sucrose, polysorbate 80. Carbidopa, levodopa and entacapone tablets 12.5 mg/50 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg and 37.5 mg/150 mg/200 mg also contain yellow iron oxide.</Description>
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<PackageDescription>1 TUBE in 1 CARTON (49348-799-32) > 51 g in 1 TUBE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark Hemorrhoidal</ProprietaryName>
<NonProprietaryName>Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>McKesson</LabelerName>
<SubstanceName>GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE; PETROLATUM</SubstanceName>
<StrengthNumber>14.4; .25; 1; 15</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
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<PackageDescription>30 TABLET in 1 BLISTER PACK (49349-799-02)</PackageDescription>
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<ProductNDC>49349-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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