{
"NDC": [
{
"NDCCode": "64092-835-24",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64092-835-24) > 24 TABLET in 1 BLISTER PACK",
"NDC11Code": "64092-0835-24",
"ProductNDC": "64092-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allerfed Cold And Allergy",
"NonProprietaryName": "Chlorpheniramine Maleate And Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020722",
"EndMarketingDate": "20191120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "4; 10",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20020722",
"EndMarketingDatePackage": "20191120",
"SamplePackage": "N"
},
{
"NDCCode": "58602-835-07",
"PackageDescription": "1 CONTAINER in 1 CARTON (58602-835-07) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "58602-0835-07",
"ProductNDC": "58602-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213266",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210803",
"SamplePackage": "N",
"IndicationAndUsage": " reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "58602-835-51",
"PackageDescription": "3 CONTAINER in 1 CARTON (58602-835-51) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "58602-0835-51",
"ProductNDC": "58602-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213266",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210803",
"SamplePackage": "N",
"IndicationAndUsage": " reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "58602-835-52",
"PackageDescription": "4 CONTAINER in 1 CARTON (58602-835-52) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "58602-0835-52",
"ProductNDC": "58602-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213266",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210803",
"SamplePackage": "N",
"IndicationAndUsage": " reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "58602-835-65",
"PackageDescription": "6 CONTAINER in 1 CARTON (58602-835-65) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "58602-0835-65",
"ProductNDC": "58602-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213266",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2022-03-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210803",
"SamplePackage": "N",
"IndicationAndUsage": " reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "71205-835-24",
"PackageDescription": "24 TABLET in 1 BOTTLE (71205-835-24) ",
"NDC11Code": "71205-0835-24",
"ProductNDC": "71205-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenazopyridine Hydrochloride",
"NonProprietaryName": "Phenazopyridine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230508",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PHENAZOPYRIDINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230606",
"SamplePackage": "N",
"IndicationAndUsage": "Phenazopyridine HCL is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).",
"Description": "Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl oral tablets contain the following inactive ingredients: Croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, maize (corn starch), microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch."
},
{
"NDCCode": "64092-012-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (64092-012-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0012-08",
"ProductNDC": "64092-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rest Simply",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000610",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-02-13"
},
{
"NDCCode": "64092-012-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-012-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0012-24",
"ProductNDC": "64092-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rest Simply",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000610",
"EndMarketingDate": "20240916",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000610",
"EndMarketingDatePackage": "20240916",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "64092-115-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (64092-115-24) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "64092-0115-24",
"ProductNDC": "64092-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Vegetable Laxative",
"NonProprietaryName": "Sennosides",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19950127",
"EndMarketingDate": "20221123",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "SENNOSIDES",
"StrengthNumber": "8.6",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19950127",
"EndMarketingDatePackage": "20221123",
"SamplePackage": "N"
},
{
"NDCCode": "64092-820-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (64092-820-08) > 24 TABLET in 1 BOTTLE",
"NDC11Code": "64092-0820-08",
"ProductNDC": "64092-820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chlor-tabs",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921219",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-01-23"
},
{
"NDCCode": "64092-820-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-820-24) / 12 TABLET in 1 BLISTER PACK",
"NDC11Code": "64092-0820-24",
"ProductNDC": "64092-820",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chlor-allergy 4-hour",
"NonProprietaryName": "Chlorpheniramine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19921219",
"EndMarketingDate": "20241019",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19921219",
"EndMarketingDatePackage": "20241019",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "64092-830-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-830-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0830-24",
"ProductNDC": "64092-830",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Complete Allergy",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19900302",
"EndMarketingDate": "20240506",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19900302",
"EndMarketingDatePackage": "20240506",
"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": "64092-845-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-845-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0845-24",
"ProductNDC": "64092-845",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Non-drowsy Sinus Daytime",
"NonProprietaryName": "Acetaminophen And Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050726",
"EndMarketingDate": "20241021",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050726",
"EndMarketingDatePackage": "20241021",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:minor aches and painsheadachenasal congestionsinus congestion and pressure. helps decongest sinus openings and passages. promotes sinus drainage. helps clear nasal passages. temporarily reduces fever."
},
{
"NDCCode": "64092-865-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-865-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0865-24",
"ProductNDC": "64092-865",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Complete Allergy And Sinus",
"ProprietaryNameSuffix": "Multi Symptom",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate And Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050628",
"EndMarketingDate": "20240725",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050628",
"EndMarketingDatePackage": "20240725",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies:headachenasal congestionrunny nose and sneezingminor aches and painssinus congestion and pressure. temporarily relieves these additional symptoms of hay fever:itchy, watery eyesitching of the nose or throat. helps clear nasal passages. helps decongest sinus openings and passages ."
},
{
"NDCCode": "64092-870-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-870-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0870-24",
"ProductNDC": "64092-870",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi-symptom Cold Daytime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050715",
"EndMarketingDate": "20240302",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050715",
"EndMarketingDatePackage": "20240302",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:minor aches and painsnasal congestionheadachecoughsinus congestion and pressuresore throat. helps clear nasal passages. promotes nasal and sinus drainage. temporarily reduces fever."
},
{
"NDCCode": "64092-112-50",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (64092-112-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "64092-0112-50",
"ProductNDC": "64092-112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Headache Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen, Aspirin And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19921117",
"EndMarketingDate": "20241024",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19921117",
"EndMarketingDatePackage": "20241024",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:toothache arthritisa coldheadachemuscular achespremenstrual and menstrual cramps."
},
{
"NDCCode": "64092-121-30",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (64092-121-30) > 15 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "64092-0121-30",
"ProductNDC": "64092-121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Womens Laxative",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150916",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150916",
"SamplePackage": "N"
},
{
"NDCCode": "37000-835-01",
"PackageDescription": "1 TUBE in 1 CARTON (37000-835-01) > 170 g in 1 TUBE",
"NDC11Code": "37000-0835-01",
"ProductNDC": "37000-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Complete Multi-benefit",
"ProprietaryNameSuffix": "Extra White Plus Crystal Clean Anti Bac",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20120806",
"EndMarketingDate": "20170120",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.6",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-01-24"
},
{
"NDCCode": "47335-835-08",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-08) ",
"NDC11Code": "47335-0835-08",
"ProductNDC": "47335-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090178",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.",
"Description": "Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-835-18",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-18) ",
"NDC11Code": "47335-0835-18",
"ProductNDC": "47335-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090178",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.",
"Description": "Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-835-83",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-83) ",
"NDC11Code": "47335-0835-83",
"ProductNDC": "47335-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090178",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.",
"Description": "Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "47335-835-88",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-88) ",
"NDC11Code": "47335-0835-88",
"ProductNDC": "47335-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Galantamine Hydrobromide",
"NonProprietaryName": "Galantamine Hydrobromide",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090178",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "GALANTAMINE HYDROBROMIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N",
"IndicationAndUsage": "Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.",
"Description": "Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water."
},
{
"NDCCode": "59651-835-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (59651-835-30) ",
"NDC11Code": "59651-0835-30",
"ProductNDC": "59651-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200082",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240301",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated:. Simvastatin. Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white or almost white powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin are available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP, providing for the following combinations: 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg. Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate."
},
{
"NDCCode": "59651-835-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (59651-835-90) ",
"NDC11Code": "59651-0835-90",
"ProductNDC": "59651-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ezetimibe And Simvastatin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200082",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240301",
"SamplePackage": "N",
"IndicationAndUsage": "Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated:. Simvastatin. Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.",
"Description": "Ezetimibe and simvastatin tablets contain ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white or almost white powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin are available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP, providing for the following combinations: 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg. Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate."
},
{
"NDCCode": "65162-835-94",
"PackageDescription": "1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE",
"NDC11Code": "65162-0835-94",
"ProductNDC": "65162-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204605",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140103",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.",
"Description": "Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "65162-835-96",
"PackageDescription": "1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE",
"NDC11Code": "65162-0835-96",
"ProductNDC": "65162-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204605",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140103",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.",
"Description": "Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
"NDCCode": "69039-835-02",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (69039-835-02) / 13 g in 1 TUBE, WITH APPLICATOR (69039-835-01) ",
"NDC11Code": "69039-0835-02",
"ProductNDC": "69039-835",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mtn. Bum By Sun Bum And Mcfetridge Mineral Sunscreen Face Stick Spf 50",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250923",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Sun Bum, LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "138",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250923",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "69097-835-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (69097-835-02) ",
"NDC11Code": "69097-0835-02",
"ProductNDC": "69097-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160721",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "69097-835-05",
"PackageDescription": "90 TABLET in 1 BOTTLE (69097-835-05) ",
"NDC11Code": "69097-0835-05",
"ProductNDC": "69097-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160721",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate."
},
{
"NDCCode": "69097-835-07",
"PackageDescription": "100 TABLET in 1 BOTTLE (69097-835-07) ",
"NDC11Code": "69097-0835-07",
"ProductNDC": "69097-835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Cipla USA Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160721",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate."
}
]
}
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<NDCList>
<NDC>
<NDCCode>64092-835-24</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64092-835-24) > 24 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0835-24</NDC11Code>
<ProductNDC>64092-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allerfed Cold And Allergy</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate And Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020722</StartMarketingDate>
<EndMarketingDate>20191120</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20020722</StartMarketingDatePackage>
<EndMarketingDatePackage>20191120</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58602-835-07</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (58602-835-07) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>58602-0835-07</NDC11Code>
<ProductNDC>58602-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213266</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58602-835-51</NDCCode>
<PackageDescription>3 CONTAINER in 1 CARTON (58602-835-51) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>58602-0835-51</NDC11Code>
<ProductNDC>58602-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
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<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213266</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
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<NDC>
<NDCCode>58602-835-52</NDCCode>
<PackageDescription>4 CONTAINER in 1 CARTON (58602-835-52) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>58602-0835-52</NDC11Code>
<ProductNDC>58602-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213266</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
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<NDC>
<NDCCode>58602-835-65</NDCCode>
<PackageDescription>6 CONTAINER in 1 CARTON (58602-835-65) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>58602-0835-65</NDC11Code>
<ProductNDC>58602-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213266</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-03-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71205-835-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (71205-835-24) </PackageDescription>
<NDC11Code>71205-0835-24</NDC11Code>
<ProductNDC>71205-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenazopyridine Hydrochloride</ProprietaryName>
<NonProprietaryName>Phenazopyridine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230508</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PHENAZOPYRIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenazopyridine HCL is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.).</IndicationAndUsage>
<Description>Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. Following is the structural formula. Phenazopyridine HCl oral tablets contain the following inactive ingredients: Croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl methyl cellulose, magnesium stearate, maize (corn starch), microcrystalline cellulose, polyethylene glycol, povidone and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>64092-012-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (64092-012-08) > 24 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0012-08</NDC11Code>
<ProductNDC>64092-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rest Simply</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000610</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-02-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>64092-012-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-012-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0012-24</NDC11Code>
<ProductNDC>64092-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rest Simply</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000610</StartMarketingDate>
<EndMarketingDate>20240916</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000610</StartMarketingDatePackage>
<EndMarketingDatePackage>20240916</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64092-115-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (64092-115-24) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>64092-0115-24</NDC11Code>
<ProductNDC>64092-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Vegetable Laxative</ProprietaryName>
<NonProprietaryName>Sennosides</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950127</StartMarketingDate>
<EndMarketingDate>20221123</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>SENNOSIDES</SubstanceName>
<StrengthNumber>8.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19950127</StartMarketingDatePackage>
<EndMarketingDatePackage>20221123</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64092-820-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (64092-820-08) > 24 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>64092-0820-08</NDC11Code>
<ProductNDC>64092-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chlor-tabs</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-23</LastUpdate>
</NDC>
<NDC>
<NDCCode>64092-820-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-820-24) / 12 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0820-24</NDC11Code>
<ProductNDC>64092-820</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chlor-allergy 4-hour</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921219</StartMarketingDate>
<EndMarketingDate>20241019</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19921219</StartMarketingDatePackage>
<EndMarketingDatePackage>20241019</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eyes, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64092-830-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-830-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0830-24</NDC11Code>
<ProductNDC>64092-830</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Complete Allergy</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900302</StartMarketingDate>
<EndMarketingDate>20240506</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19900302</StartMarketingDatePackage>
<EndMarketingDatePackage>20240506</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>64092-845-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-845-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0845-24</NDC11Code>
<ProductNDC>64092-845</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Non-drowsy Sinus Daytime</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20050726</StartMarketingDate>
<EndMarketingDate>20241021</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050726</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:minor aches and painsheadachenasal congestionsinus congestion and pressure. helps decongest sinus openings and passages. promotes sinus drainage. helps clear nasal passages. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-865-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Complete Allergy And Sinus</ProprietaryName>
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<StartMarketingDate>20050628</StartMarketingDate>
<EndMarketingDate>20240725</EndMarketingDate>
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<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050628</StartMarketingDatePackage>
<EndMarketingDatePackage>20240725</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies:headachenasal congestionrunny nose and sneezingminor aches and painssinus congestion and pressure. temporarily relieves these additional symptoms of hay fever:itchy, watery eyesitching of the nose or throat. helps clear nasal passages. helps decongest sinus openings and passages .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64092-870-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-870-24) / 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0870-24</NDC11Code>
<ProductNDC>64092-870</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Multi-symptom Cold Daytime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050715</StartMarketingDate>
<EndMarketingDate>20240302</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050715</StartMarketingDatePackage>
<EndMarketingDatePackage>20240302</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:minor aches and painsnasal congestionheadachecoughsinus congestion and pressuresore throat. helps clear nasal passages. promotes nasal and sinus drainage. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64092-112-50</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (64092-112-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>64092-0112-50</NDC11Code>
<ProductNDC>64092-112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Headache Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19921117</StartMarketingDate>
<EndMarketingDate>20241024</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19921117</StartMarketingDatePackage>
<EndMarketingDatePackage>20241024</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:toothache arthritisa coldheadachemuscular achespremenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64092-121-30</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (64092-121-30) > 15 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>64092-0121-30</NDC11Code>
<ProductNDC>64092-121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Womens Laxative</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150916</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-835-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37000-835-01) > 170 g in 1 TUBE</PackageDescription>
<NDC11Code>37000-0835-01</NDC11Code>
<ProductNDC>37000-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Complete Multi-benefit</ProprietaryName>
<ProprietaryNameSuffix>Extra White Plus Crystal Clean Anti Bac</ProprietaryNameSuffix>
<NonProprietaryName>Stannous Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20120806</StartMarketingDate>
<EndMarketingDate>20170120</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>STANNOUS FLUORIDE</SubstanceName>
<StrengthNumber>1.6</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>47335-835-08</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-08) </PackageDescription>
<NDC11Code>47335-0835-08</NDC11Code>
<ProductNDC>47335-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090178</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-835-18</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-18) </PackageDescription>
<NDC11Code>47335-0835-18</NDC11Code>
<ProductNDC>47335-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090178</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-835-83</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-83) </PackageDescription>
<NDC11Code>47335-0835-83</NDC11Code>
<ProductNDC>47335-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090178</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>47335-835-88</NDCCode>
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<NDC11Code>47335-0835-88</NDC11Code>
<ProductNDC>47335-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Galantamine Hydrobromide</ProprietaryName>
<NonProprietaryName>Galantamine Hydrobromide</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090178</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>GALANTAMINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Galantamine hydrobromide extended-release capsules contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)- 4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro [3a,3,2-ef][2]benzazepin-6-ol hydrobromide. It has a molecular formula of C17H21NO3HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is. Galantamine hydrobromide extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, USP, respectively. Inactive ingredients include pregelatinized maize starch, hypromellose, hydroxy propyl cellulose, colloidal silicon dioxide, magnesium stearate. The 16 mg capsule also contains ferric oxide (red). The 24 mg capsule also contains FD & C Yellow 6 Lake (15 to 18%). The capsule shells contain gelatin, and sodium lauryl sulfate. The capsule shells also contain one or more of the following: titanium dioxide, iron oxide red, iron oxide yellow. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>59651-835-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59651-835-30) </PackageDescription>
<NDC11Code>59651-0835-30</NDC11Code>
<ProductNDC>59651-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200082</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated:. Simvastatin. Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white or almost white powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin are available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP, providing for the following combinations: 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg. Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>59651-835-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (59651-835-90) </PackageDescription>
<NDC11Code>59651-0835-90</NDC11Code>
<ProductNDC>59651-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200082</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ezetimibe and simvastatin tablets. Ezetimibe and simvastatin tablet is a combination of simvastatin and ezetimibe indicated:. Simvastatin. Simvastatin, when used as a component of ezetimibe and simvastatin tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.</IndicationAndUsage>
<Description>Ezetimibe and simvastatin tablets contain ezetimibe, a dietary cholesterol absorption inhibitor, and simvastatin, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4. Ezetimibe, USP is a white powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Simvastatin, USP is a white or almost white powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin are available for oral use as tablets containing 10 mg of ezetimibe USP, and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP, providing for the following combinations: 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg or 10 mg/80 mg. Each tablet contains the following inactive ingredients: ascorbic acid, butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate.</Description>
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<NDC>
<NDCCode>65162-835-94</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>65162-0835-94</NDC11Code>
<ProductNDC>65162-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204605</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>65162-835-96</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>65162-0835-96</NDC11Code>
<ProductNDC>65162-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204605</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir, USP, is a synthetic nucleoside analogue active against herpes viruses. Acyclovir ointment, USP 5% is a formulation for topical administration. Each gram of acyclovir ointment, USP 5% contains 50 mg of acyclovir, USP in a polyethylene glycol (PEG) base. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>69039-835-02</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (69039-835-02) / 13 g in 1 TUBE, WITH APPLICATOR (69039-835-01) </PackageDescription>
<NDC11Code>69039-0835-02</NDC11Code>
<ProductNDC>69039-835</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mtn. Bum By Sun Bum And Mcfetridge Mineral Sunscreen Face Stick Spf 50</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Sun Bum, LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>138</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures, (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69097-835-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69097-835-02) </PackageDescription>
<NDC11Code>69097-0835-02</NDC11Code>
<ProductNDC>69097-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69097-835-05</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (69097-835-05) </PackageDescription>
<NDC11Code>69097-0835-05</NDC11Code>
<ProductNDC>69097-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>69097-835-07</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69097-835-07) </PackageDescription>
<NDC11Code>69097-0835-07</NDC11Code>
<ProductNDC>69097-835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Cipla USA Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloride tablets, USP for oral administration are supplied as scored tablets containing 27.98 mg, 55.9 mg and 111.9 mg sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, ascorbic acid, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate.</Description>
</NDC>
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