{
"NDC": [
{
"NDCCode": "57841-1305-2",
"PackageDescription": "6 BOX in 1 CARTON (57841-1305-2) > 3 POUCH in 1 BOX > 1 FILM, SOLUBLE in 1 POUCH (57841-1305-1)",
"NDC11Code": "57841-1305-02",
"ProductNDC": "57841-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Not Yet Defined",
"NonProprietaryName": "Rizatriptan Benzoate Oral Films",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "RedHill Biopharma Ltd.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-05-01"
},
{
"NDCCode": "57841-1150-2",
"PackageDescription": "2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1) ",
"NDC11Code": "57841-1150-02",
"ProductNDC": "57841-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talicia",
"NonProprietaryName": "Omeprazole Magnesium, Amoxicillin And Rifabutin",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213004",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN",
"StrengthNumber": "10; 250; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200309",
"SamplePackage": "N",
"Description": "TALICIA delayed-release capsules contain omeprazole magnesium, amoxicillin and rifabutin for oral administration. Omeprazole magnesium is included in the delayed-release component of the capsule, and amoxicillin and rifabutin are included in the immediate-release component of the capsule. Each delayed-release capsule contains: 1 omeprazole 10 mg (equivalent to 10.3 mg of omeprazole magnesium), 2 amoxicillin 250 mg (equivalent to 286.9 mg of amoxicillin trihydrate), 3 rifabutin 12.5 mg."
},
{
"NDCCode": "57841-1150-4",
"PackageDescription": "2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3) ",
"NDC11Code": "57841-1150-04",
"ProductNDC": "57841-1150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talicia",
"NonProprietaryName": "Omeprazole Magnesium, Amoxicillin And Rifabutin",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213004",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN",
"StrengthNumber": "10; 250; 12.5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210924",
"SamplePackage": "Y",
"Description": "TALICIA delayed-release capsules contain omeprazole magnesium, amoxicillin and rifabutin for oral administration. Omeprazole magnesium is included in the delayed-release component of the capsule, and amoxicillin and rifabutin are included in the immediate-release component of the capsule. Each delayed-release capsule contains: 1 omeprazole 10 mg (equivalent to 10.3 mg of omeprazole magnesium), 2 amoxicillin 250 mg (equivalent to 286.9 mg of amoxicillin trihydrate), 3 rifabutin 12.5 mg."
},
{
"NDCCode": "57841-1200-1",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (57841-1200-1) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) ",
"NDC11Code": "57841-1200-01",
"ProductNDC": "57841-1200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aemcolo",
"NonProprietaryName": "Rifamycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210910",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "RIFAMYCIN",
"StrengthNumber": "194",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).",
"Description": "AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide."
},
{
"NDCCode": "57841-1200-2",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (57841-1200-2) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) ",
"NDC11Code": "57841-1200-02",
"ProductNDC": "57841-1200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aemcolo",
"NonProprietaryName": "Rifamycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210910",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "RIFAMYCIN",
"StrengthNumber": "194",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).",
"Description": "AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide."
},
{
"NDCCode": "57841-1300-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (57841-1300-2) ",
"NDC11Code": "57841-1300-02",
"ProductNDC": "57841-1300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Movantik",
"NonProprietaryName": "Naloxegol Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"EndMarketingDate": "20250630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204760",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "NALOXEGOL OXALATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201001",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.",
"Description": "MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "57841-1301-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2) ",
"NDC11Code": "57841-1301-02",
"ProductNDC": "57841-1301",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Movantik",
"NonProprietaryName": "Naloxegol Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"EndMarketingDate": "20270131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204760",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "NALOXEGOL OXALATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201001",
"EndMarketingDatePackage": "20270131",
"SamplePackage": "N",
"IndicationAndUsage": "MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.",
"Description": "MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black."
},
{
"NDCCode": "57841-1310-2",
"PackageDescription": "6 BOX in 1 CARTON (57841-1310-2) > 3 POUCH in 1 BOX > 1 FILM, SOLUBLE in 1 POUCH (57841-1310-1)",
"NDC11Code": "57841-1310-02",
"ProductNDC": "57841-1310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Not Yet Defined",
"NonProprietaryName": "Rizatriptan Benzoate Oral Films",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "RedHill Biopharma Ltd.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-05-01"
},
{
"NDCCode": "57841-1405-2",
"PackageDescription": "18 POUCH in 1 CARTON (57841-1405-2) > 1 FILM, SOLUBLE in 1 POUCH (57841-1405-1)",
"NDC11Code": "57841-1405-02",
"ProductNDC": "57841-1405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizaport",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "RedHill Biopharma Ltd.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "5",
"StrengthUnit": "1/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "57841-1410-2",
"PackageDescription": "18 POUCH in 1 CARTON (57841-1410-2) > 1 FILM, SOLUBLE in 1 POUCH (57841-1410-1)",
"NDC11Code": "57841-1410-02",
"ProductNDC": "57841-1410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rizaport",
"NonProprietaryName": "Rizatriptan Benzoate",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205394",
"LabelerName": "RedHill Biopharma Ltd.",
"SubstanceName": "RIZATRIPTAN BENZOATE",
"StrengthNumber": "10",
"StrengthUnit": "1/1",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "11523-1305-2",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (11523-1305-2) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11523-1305-02",
"ProductNDC": "11523-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coricidin Hbp Maximum Strength Flu",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000831",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "MSD Consumer Care, Inc.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 2; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16853-1305-2",
"PackageDescription": "1 BLISTER PACK in 1 BOX (16853-1305-2) > 10 TABLET in 1 BLISTER PACK (16853-1305-1)",
"NDC11Code": "16853-1305-02",
"ProductNDC": "16853-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alleroff",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019835",
"LabelerName": "Corporacion Infarmasa",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "16853-1305-3",
"PackageDescription": "2 TABLET in 1 BLISTER PACK (16853-1305-3)",
"NDC11Code": "16853-1305-03",
"ProductNDC": "16853-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alleroff",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019835",
"LabelerName": "Corporacion Infarmasa",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "22840-1305-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1305-2) ",
"NDC11Code": "22840-1305-02",
"ProductNDC": "22840-1305",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Burrobrush",
"NonProprietaryName": "Hymenoclea Salsola",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "AMBROSIA SALSOLA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "36987-1305-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1305-2)",
"NDC11Code": "36987-1305-02",
"ProductNDC": "36987-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Blueberry",
"NonProprietaryName": "Blueberry",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "BLUEBERRY",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1305-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-1305-2) ",
"NDC11Code": "37662-1305-02",
"ProductNDC": "37662-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Veratrum Album",
"NonProprietaryName": "Veratrum Album",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220811",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "VERATRUM ALBUM ROOT",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220811",
"SamplePackage": "N"
},
{
"NDCCode": "49452-1305-2",
"PackageDescription": "5 g in 1 BOTTLE, GLASS (49452-1305-2)",
"NDC11Code": "49452-1305-02",
"ProductNDC": "49452-1305",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bromhexine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "19971001",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "BROMHEXINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "60681-1305-2",
"PackageDescription": "50 VIAL, GLASS in 1 CARTON (60681-1305-2) > 1 mL in 1 VIAL, GLASS",
"NDC11Code": "60681-1305-02",
"ProductNDC": "60681-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pleo San Trich",
"NonProprietaryName": "Trichophyton Verrucosum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19970430",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Sanum Kehlbeck GmbH & Co. KG",
"SubstanceName": "TRICHOPHYTON VERRUCOSUM",
"StrengthNumber": "5",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For temporary relief of fungal infections."
},
{
"NDCCode": "64942-1305-2",
"PackageDescription": "1 TUBE in 1 CARTON (64942-1305-2) > 100 mL in 1 TUBE (64942-1305-1) ",
"NDC11Code": "64942-1305-02",
"ProductNDC": "64942-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dove Dermaseries",
"ProprietaryNameSuffix": "Rough Patch Treatment",
"NonProprietaryName": "Dimethicone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131010",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Conopco Inc. d/b/a Unilever",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "1.1",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20131010",
"SamplePackage": "N",
"IndicationAndUsage": "Uses ● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "71335-1305-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (71335-1305-2) ",
"NDC11Code": "71335-1305-02",
"ProductNDC": "71335-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levocetirizine Dihydrochloride",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202046",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210309",
"SamplePackage": "N",
"IndicationAndUsage": "Levocetirizine dihydrochloride is a histamine H 1-receptor antagonist indicated for:.",
"Description": "Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablet USP, is an orally active H 1-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The molecular formula of levocetirizine dihydrochloride is C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Levocetirizine dihydrochloride is a white to off white powder and is freely soluble in water and in methanol. Levocetirizine dihydrochloride tablets USP, 5 mg are formulated as immediate release, white to off white, oval shaped biconvex, film-coated tablet for oral administration. The tablets are debossed with 'I' and '12' on one side and score line on the other side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol."
},
{
"NDCCode": "0069-1305-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1305-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1305-01) ",
"NDC11Code": "00069-1305-10",
"ProductNDC": "0069-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Retacrit",
"NonProprietaryName": "Epoetin Alfa-epbx",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20180618",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125545",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "EPOETIN",
"StrengthNumber": "2000",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180618",
"SamplePackage": "N",
"IndicationAndUsage": "RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).",
"Description": "Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6)."
},
{
"NDCCode": "0338-1305-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00338-1305-01",
"ProductNDC": "0338-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesnex",
"NonProprietaryName": "Mesna",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019884",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "MESNA",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytoprotective Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.",
"Description": "MESNEX (mesna) is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows. HS–CH2–CH2SO3–Na+. MESNEX injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. MESNEX injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. MESNEX injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5. MESNEX tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide."
},
{
"NDCCode": "0338-1305-03",
"PackageDescription": "10 VIAL, MULTI-DOSE in 1 BOX (0338-1305-03) / 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00338-1305-03",
"ProductNDC": "0338-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesnex",
"NonProprietaryName": "Mesna",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19881230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019884",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "MESNA",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytoprotective Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19881230",
"SamplePackage": "N",
"IndicationAndUsage": "MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.",
"Description": "MESNEX (mesna) is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows. HS–CH2–CH2SO3–Na+. MESNEX injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. MESNEX injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. MESNEX injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5. MESNEX tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide."
},
{
"NDCCode": "11523-1305-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (11523-1305-1) > 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "11523-1305-01",
"ProductNDC": "11523-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coricidin Hbp Maximum Strength Flu",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20000831",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "MSD Consumer Care, Inc.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 2; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-04-04",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11523-1305-9",
"PackageDescription": "12507 TABLET, FILM COATED in 1 DRUM (11523-1305-9) ",
"NDC11Code": "11523-1305-09",
"ProductNDC": "11523-1305",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Coric Max Flu Nt P26-143e Asesica, C-night/coricidin Ni 2/15/500 Mer Fta001l",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "500; 2; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2025-12-16",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "01-MAR-16"
},
{
"NDCCode": "43742-1305-1",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (43742-1305-1) ",
"NDC11Code": "43742-1305-01",
"ProductNDC": "43742-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kidney Drainage",
"NonProprietaryName": "Solidago Virgaurea, Asparagus Officinalis, Juniperus Communis, Sabal Serrulata, Uva Ursi, Berberis Vulgaris, Equisetum Arvense, Urtica Dioica, Rubia Tinctorum, Staphysagria, Cantharis, Cobaltum Metallicum, Fagus Sylvatica Flos, Glandula Suprarenalis Suis, Hepar Sulphuris Calcareum, Kidney (suis), Larix Decidua Flos, Manganum Metallicum, Mimulus Guttatus Flos, Nitricum Acidum, Rhus Aromatica, Silicea, Ulex Europaeus Flos, Benzoicum Acidum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"EndMarketingDate": "20240528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "ARCTOSTAPHYLOS UVA-URSI LEAF; ASPARAGUS; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; COBALT; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM ARVENSE TOP; FAGUS SYLVATICA FLOWERING TOP; JUNIPERUS COMMUNIS WHOLE; LARIX DECIDUA FLOWERING TOP; LYTTA VESICATORIA; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; PORK KIDNEY; RHUS AROMATICA ROOT BARK; RUBIA TINCTORUM ROOT; SAW PALMETTO; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ULEX EUROPAEUS FLOWER; URTICA DIOICA",
"StrengthNumber": "2; 2; 12; 3; 8; 8; 6; 3; 8; 2; 8; 8; 8; 8; 8; 8; 8; 6; 2; 8; 1; 8; 8; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrogen Binding Agent [EPC], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180904",
"EndMarketingDatePackage": "20240528",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of symptoms related to kidney drainage, such as fatigue.**. **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "51672-1305-3",
"PackageDescription": "1 BOTTLE in 1 CARTON (51672-1305-3) / 30 mL in 1 BOTTLE",
"NDC11Code": "51672-1305-03",
"ProductNDC": "51672-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076788",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060315",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.",
"Description": "Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.4 and the following structural formula:. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains 1 mg mometasone furoate in a colorless, clear to translucent lotion base of hydroxypropyl cellulose, isopropyl alcohol 40% v/v, phosphoric acid, propylene glycol, purified water and sodium phosphate monobasic."
},
{
"NDCCode": "51672-1305-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (51672-1305-4) / 60 mL in 1 BOTTLE",
"NDC11Code": "51672-1305-04",
"ProductNDC": "51672-1305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076788",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060315",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.",
"Description": "Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.4 and the following structural formula:. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains 1 mg mometasone furoate in a colorless, clear to translucent lotion base of hydroxypropyl cellulose, isopropyl alcohol 40% v/v, phosphoric acid, propylene glycol, purified water and sodium phosphate monobasic."
},
{
"NDCCode": "53346-1305-5",
"PackageDescription": "50 mL in 1 BOTTLE (53346-1305-5)",
"NDC11Code": "53346-1305-05",
"ProductNDC": "53346-1305",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr. Reckeweg R5 Gastreu",
"ProprietaryNameSuffix": "Combination Product",
"NonProprietaryName": "Anacardium Orientale 6x, Argentum Nitricum 6x, Arsenicum Album 6x, Belladonna 4x, Carbo Vegetabilis 8x, Chamomilla 2x, Chelidonium Majus, Radix 3x, Lycopodium Clavatum 5x, Nux Vomica 4x, Scrophularia Nodosa 1x",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19860601",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO",
"SubstanceName": "SEMECARPUS ANACARDIUM FRUIT; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CHELIDONIUM MAJUS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SCROPHULARIA NODOSA",
"StrengthNumber": "6; 6; 6; 4; 8; 2; 3; 5; 4; 1",
"StrengthUnit": "[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses. For the temporary relief of."
},
{
"NDCCode": "57841-1201-1",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57841-1201-1) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1201-0) ",
"NDC11Code": "57841-1201-01",
"ProductNDC": "57841-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aemcolo",
"NonProprietaryName": "Rifamycin",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210910",
"LabelerName": "RedHill Biopharma Ltd",
"SubstanceName": "RIFAMYCIN",
"StrengthNumber": "194",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210701",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).",
"Description": "AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>57841-1305-2</NDCCode>
<PackageDescription>6 BOX in 1 CARTON (57841-1305-2) > 3 POUCH in 1 BOX > 1 FILM, SOLUBLE in 1 POUCH (57841-1305-1)</PackageDescription>
<NDC11Code>57841-1305-02</NDC11Code>
<ProductNDC>57841-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Not Yet Defined</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate Oral Films</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>57841-1150-2</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (57841-1150-2) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-1) </PackageDescription>
<NDC11Code>57841-1150-02</NDC11Code>
<ProductNDC>57841-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talicia</ProprietaryName>
<NonProprietaryName>Omeprazole Magnesium, Amoxicillin And Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213004</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN</SubstanceName>
<StrengthNumber>10; 250; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>TALICIA delayed-release capsules contain omeprazole magnesium, amoxicillin and rifabutin for oral administration. Omeprazole magnesium is included in the delayed-release component of the capsule, and amoxicillin and rifabutin are included in the immediate-release component of the capsule. Each delayed-release capsule contains: 1 omeprazole 10 mg (equivalent to 10.3 mg of omeprazole magnesium), 2 amoxicillin 250 mg (equivalent to 286.9 mg of amoxicillin trihydrate), 3 rifabutin 12.5 mg.</Description>
</NDC>
<NDC>
<NDCCode>57841-1150-4</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (57841-1150-4) / 84 CAPSULE, DELAYED RELEASE in 1 BOTTLE (57841-1150-3) </PackageDescription>
<NDC11Code>57841-1150-04</NDC11Code>
<ProductNDC>57841-1150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talicia</ProprietaryName>
<NonProprietaryName>Omeprazole Magnesium, Amoxicillin And Rifabutin</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213004</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>OMEPRAZOLE MAGNESIUM; AMOXICILLIN; RIFABUTIN</SubstanceName>
<StrengthNumber>10; 250; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Penicillin-class Antibacterial [EPC], Penicillins [CS], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA], Rifamycin Antimycobacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210924</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<Description>TALICIA delayed-release capsules contain omeprazole magnesium, amoxicillin and rifabutin for oral administration. Omeprazole magnesium is included in the delayed-release component of the capsule, and amoxicillin and rifabutin are included in the immediate-release component of the capsule. Each delayed-release capsule contains: 1 omeprazole 10 mg (equivalent to 10.3 mg of omeprazole magnesium), 2 amoxicillin 250 mg (equivalent to 286.9 mg of amoxicillin trihydrate), 3 rifabutin 12.5 mg.</Description>
</NDC>
<NDC>
<NDCCode>57841-1200-1</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (57841-1200-1) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) </PackageDescription>
<NDC11Code>57841-1200-01</NDC11Code>
<ProductNDC>57841-1200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aemcolo</ProprietaryName>
<NonProprietaryName>Rifamycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210910</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>RIFAMYCIN</SubstanceName>
<StrengthNumber>194</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).</IndicationAndUsage>
<Description>AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>57841-1200-2</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (57841-1200-2) / 6 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1200-0) </PackageDescription>
<NDC11Code>57841-1200-02</NDC11Code>
<ProductNDC>57841-1200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aemcolo</ProprietaryName>
<NonProprietaryName>Rifamycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210910</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>RIFAMYCIN</SubstanceName>
<StrengthNumber>194</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).</IndicationAndUsage>
<Description>AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>57841-1300-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (57841-1300-2) </PackageDescription>
<NDC11Code>57841-1300-02</NDC11Code>
<ProductNDC>57841-1300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Movantik</ProprietaryName>
<NonProprietaryName>Naloxegol Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<EndMarketingDate>20250630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204760</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>NALOXEGOL OXALATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<EndMarketingDatePackage>20250630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.</IndicationAndUsage>
<Description>MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>57841-1301-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2) </PackageDescription>
<NDC11Code>57841-1301-02</NDC11Code>
<ProductNDC>57841-1301</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Movantik</ProprietaryName>
<NonProprietaryName>Naloxegol Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<EndMarketingDate>20270131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204760</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>NALOXEGOL OXALATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<EndMarketingDatePackage>20270131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MOVANTIK ®is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.</IndicationAndUsage>
<Description>MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.). The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate. The structural formula is. The empirical formula for naloxegol oxalate is C 34H 53NO 11.C 2H 2O 4and the molecular weight is 742. Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range. MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol. Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate. Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>57841-1310-2</NDCCode>
<PackageDescription>6 BOX in 1 CARTON (57841-1310-2) > 3 POUCH in 1 BOX > 1 FILM, SOLUBLE in 1 POUCH (57841-1310-1)</PackageDescription>
<NDC11Code>57841-1310-02</NDC11Code>
<ProductNDC>57841-1310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Not Yet Defined</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate Oral Films</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>57841-1405-2</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (57841-1405-2) > 1 FILM, SOLUBLE in 1 POUCH (57841-1405-1)</PackageDescription>
<NDC11Code>57841-1405-02</NDC11Code>
<ProductNDC>57841-1405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizaport</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>57841-1410-2</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (57841-1410-2) > 1 FILM, SOLUBLE in 1 POUCH (57841-1410-1)</PackageDescription>
<NDC11Code>57841-1410-02</NDC11Code>
<ProductNDC>57841-1410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rizaport</ProprietaryName>
<NonProprietaryName>Rizatriptan Benzoate</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205394</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd.</LabelerName>
<SubstanceName>RIZATRIPTAN BENZOATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>11523-1305-2</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (11523-1305-2) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11523-1305-02</NDC11Code>
<ProductNDC>11523-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coricidin Hbp Maximum Strength Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>MSD Consumer Care, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>500; 2; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16853-1305-2</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 BOX (16853-1305-2) > 10 TABLET in 1 BLISTER PACK (16853-1305-1)</PackageDescription>
<NDC11Code>16853-1305-02</NDC11Code>
<ProductNDC>16853-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alleroff</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019835</ApplicationNumber>
<LabelerName>Corporacion Infarmasa</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16853-1305-3</NDCCode>
<PackageDescription>2 TABLET in 1 BLISTER PACK (16853-1305-3)</PackageDescription>
<NDC11Code>16853-1305-03</NDC11Code>
<ProductNDC>16853-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alleroff</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019835</ApplicationNumber>
<LabelerName>Corporacion Infarmasa</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>22840-1305-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1305-2) </PackageDescription>
<NDC11Code>22840-1305-02</NDC11Code>
<ProductNDC>22840-1305</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Burrobrush</ProprietaryName>
<NonProprietaryName>Hymenoclea Salsola</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>AMBROSIA SALSOLA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>36987-1305-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1305-2)</PackageDescription>
<NDC11Code>36987-1305-02</NDC11Code>
<ProductNDC>36987-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Blueberry</ProprietaryName>
<NonProprietaryName>Blueberry</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>BLUEBERRY</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1305-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-1305-2) </PackageDescription>
<NDC11Code>37662-1305-02</NDC11Code>
<ProductNDC>37662-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Veratrum Album</ProprietaryName>
<NonProprietaryName>Veratrum Album</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220811</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49452-1305-2</NDCCode>
<PackageDescription>5 g in 1 BOTTLE, GLASS (49452-1305-2)</PackageDescription>
<NDC11Code>49452-1305-02</NDC11Code>
<ProductNDC>49452-1305</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bromhexine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19971001</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>BROMHEXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60681-1305-2</NDCCode>
<PackageDescription>50 VIAL, GLASS in 1 CARTON (60681-1305-2) > 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>60681-1305-02</NDC11Code>
<ProductNDC>60681-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pleo San Trich</ProprietaryName>
<NonProprietaryName>Trichophyton Verrucosum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Sanum Kehlbeck GmbH & Co. KG</LabelerName>
<SubstanceName>TRICHOPHYTON VERRUCOSUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For temporary relief of fungal infections.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64942-1305-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (64942-1305-2) > 100 mL in 1 TUBE (64942-1305-1) </PackageDescription>
<NDC11Code>64942-1305-02</NDC11Code>
<ProductNDC>64942-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dove Dermaseries</ProprietaryName>
<ProprietaryNameSuffix>Rough Patch Treatment</ProprietaryNameSuffix>
<NonProprietaryName>Dimethicone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131010</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a Unilever</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses ● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1305-2</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (71335-1305-2) </PackageDescription>
<NDC11Code>71335-1305-02</NDC11Code>
<ProductNDC>71335-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levocetirizine Dihydrochloride</ProprietaryName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202046</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levocetirizine dihydrochloride is a histamine H 1-receptor antagonist indicated for:.</IndicationAndUsage>
<Description>Levocetirizine dihydrochloride, the active component of levocetirizine dihydrochloride tablet USP, is an orally active H 1-receptor antagonist. The chemical name is (R)-[2-[4-[(4-chlorophenyl) phenylmethyl]-1-piperazinyl] ethoxy] acetic acid dihydrochloride. Levocetirizine dihydrochloride is the R enantiomer of cetirizine hydrochloride, a racemic compound with antihistaminic properties. The molecular formula of levocetirizine dihydrochloride is C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Levocetirizine dihydrochloride is a white to off white powder and is freely soluble in water and in methanol. Levocetirizine dihydrochloride tablets USP, 5 mg are formulated as immediate release, white to off white, oval shaped biconvex, film-coated tablet for oral administration. The tablets are debossed with 'I' and '12' on one side and score line on the other side. Inactive ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0069-1305-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0069-1305-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-1305-01) </PackageDescription>
<NDC11Code>00069-1305-10</NDC11Code>
<ProductNDC>0069-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Retacrit</ProprietaryName>
<NonProprietaryName>Epoetin Alfa-epbx</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20180618</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125545</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>EPOETIN</SubstanceName>
<StrengthNumber>2000</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for: 1 Treatment of anemia due tooChronic Kidney Disease (CKD) in patients on dialysis and not on dialysis (1.1).oZidovudine in patients with Human Immunodeficiency Virus (HIV) infection (1.2).oThe effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy (1.3)., 2 Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery (1.4).</IndicationAndUsage>
<Description>Epoetin alfa-epbx is an erythropoiesis-stimulating agent. Epoetin alfa-epbx is a 165-amino acid glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced in Chinese Hamster Ovary (CHO) cell line. The product contains the identical amino acid sequence of isolated natural erythropoietin. RETACRIT (epoetin alfa-epbx) injection for intravenous or subcutaneous administration is a sterile, clear, colorless solution in vials in multiple formulations. Each 1 mL single-dose vial of 2,000, 3,000, 4,000, and 10,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.4 mg), sodium phosphate dibasic anhydrous (4.9 mg), sodium phosphate monobasic monohydrate (1.3 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL single-dose vial of 40,000 Units of epoetin alfa-epbx contains calcium chloride dihydrate (0.01 mg), glycine (7.5 mg), isoleucine (1 mg), leucine (1 mg), L-glutamic acid (0.25 mg), phenylalanine (0.5 mg), polysorbate 20 (0.1 mg), sodium chloride (2.2 mg), sodium phosphate dibasic anhydrous (5.7 mg), sodium phosphate monobasic monohydrate (1.5 mg), and threonine (0.25 mg), in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 7.0 – 7.5). Each 1 mL multiple-dose vial of 20,000 Units of epoetin alfa-epbx contains benzyl alcohol (8.5 mg), L-methionine (0.45 mg), polysorbate 20 (0.04 mg), sodium phosphate dibasic anhydrous (0.09 mg), sodium phosphate monobasic monohydrate (2.67 mg), and sucrose (60 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6). Each 2 mL multiple-dose vial of 20,000 Units (10,000 Units/mL) of epoetin alfa-epbx contains benzyl alcohol (17 mg), L-methionine (0.9 mg), polysorbate 20 (0.08 mg), sodium phosphate dibasic anhydrous (0.18 mg), sodium phosphate monobasic monohydrate (5.34 mg), and sucrose (120 mg) in Water for Injection, USP. Sodium hydroxide and hydrochloric acid may be added to adjust the pH (pH 5.6 – 6.6).</Description>
</NDC>
<NDC>
<NDCCode>0338-1305-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (0338-1305-01) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00338-1305-01</NDC11Code>
<ProductNDC>0338-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesnex</ProprietaryName>
<NonProprietaryName>Mesna</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019884</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>MESNA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.</IndicationAndUsage>
<Description>MESNEX (mesna) is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows. HS–CH2–CH2SO3–Na+. MESNEX injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. MESNEX injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. MESNEX injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5. MESNEX tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0338-1305-03</NDCCode>
<PackageDescription>10 VIAL, MULTI-DOSE in 1 BOX (0338-1305-03) / 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00338-1305-03</NDC11Code>
<ProductNDC>0338-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesnex</ProprietaryName>
<NonProprietaryName>Mesna</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19881230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019884</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>MESNA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation of Use: MESNEX is not indicated to reduce the risk of hematuria due to other pathological conditions such as thrombocytopenia.</IndicationAndUsage>
<Description>MESNEX (mesna) is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows. HS–CH2–CH2SO3–Na+. MESNEX injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multidose vials for intravenous administration. MESNEX injection contains 100 mg/mL mesna, 0.25 mg/mL edetate disodium and sodium hydroxide for pH adjustment. MESNEX injection multidose vials also contain 10.4 mg/mL of benzyl alcohol as a preservative. The solution has a pH range of 7.5-8.5. MESNEX tablets are white, oblong, scored biconvex film-coated tablets with the imprint M4. They contain 400 mg mesna. The excipients are calcium phosphate, cornstarch, hydroxypropylmethylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, simethicone, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>11523-1305-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (11523-1305-1) > 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>11523-1305-01</NDC11Code>
<ProductNDC>11523-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coricidin Hbp Maximum Strength Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Dextromethorphan Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>MSD Consumer Care, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>500; 2; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-04-04</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11523-1305-9</NDCCode>
<PackageDescription>12507 TABLET, FILM COATED in 1 DRUM (11523-1305-9) </PackageDescription>
<NDC11Code>11523-1305-09</NDC11Code>
<ProductNDC>11523-1305</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Coric Max Flu Nt P26-143e Asesica, C-night/coricidin Ni 2/15/500 Mer Fta001l</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>500; 2; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAR-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43742-1305-1</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (43742-1305-1) </PackageDescription>
<NDC11Code>43742-1305-01</NDC11Code>
<ProductNDC>43742-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kidney Drainage</ProprietaryName>
<NonProprietaryName>Solidago Virgaurea, Asparagus Officinalis, Juniperus Communis, Sabal Serrulata, Uva Ursi, Berberis Vulgaris, Equisetum Arvense, Urtica Dioica, Rubia Tinctorum, Staphysagria, Cantharis, Cobaltum Metallicum, Fagus Sylvatica Flos, Glandula Suprarenalis Suis, Hepar Sulphuris Calcareum, Kidney (suis), Larix Decidua Flos, Manganum Metallicum, Mimulus Guttatus Flos, Nitricum Acidum, Rhus Aromatica, Silicea, Ulex Europaeus Flos, Benzoicum Acidum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<EndMarketingDate>20240528</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>ARCTOSTAPHYLOS UVA-URSI LEAF; ASPARAGUS; BENZOIC ACID; BERBERIS VULGARIS ROOT BARK; CALCIUM SULFIDE; COBALT; DELPHINIUM STAPHISAGRIA SEED; EQUISETUM ARVENSE TOP; FAGUS SYLVATICA FLOWERING TOP; JUNIPERUS COMMUNIS WHOLE; LARIX DECIDUA FLOWERING TOP; LYTTA VESICATORIA; MANGANESE; MIMULUS GUTTATUS FLOWERING TOP; NITRIC ACID; PORK KIDNEY; RHUS AROMATICA ROOT BARK; RUBIA TINCTORUM ROOT; SAW PALMETTO; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA ADRENAL GLAND; ULEX EUROPAEUS FLOWER; URTICA DIOICA</SubstanceName>
<StrengthNumber>2; 2; 12; 3; 8; 8; 6; 3; 8; 2; 8; 8; 8; 8; 8; 8; 8; 6; 2; 8; 1; 8; 8; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Nitrogen Binding Agent [EPC], Non-Standardized Food Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<EndMarketingDatePackage>20240528</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of symptoms related to kidney drainage, such as fatigue.**. **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51672-1305-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51672-1305-3) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51672-1305-03</NDC11Code>
<ProductNDC>51672-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076788</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.</IndicationAndUsage>
<Description>Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.4 and the following structural formula:. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains 1 mg mometasone furoate in a colorless, clear to translucent lotion base of hydroxypropyl cellulose, isopropyl alcohol 40% v/v, phosphoric acid, propylene glycol, purified water and sodium phosphate monobasic.</Description>
</NDC>
<NDC>
<NDCCode>51672-1305-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51672-1305-4) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>51672-1305-04</NDC11Code>
<ProductNDC>51672-1305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076788</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone Furoate Topical Solution USP, 0.1% (Lotion) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older.</IndicationAndUsage>
<Description>Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains mometasone furoate for topical use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate is 9α, 21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C 27H 30Cl 2O 6, a molecular weight of 521.4 and the following structural formula:. Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol. Each gram of Mometasone Furoate Topical Solution USP, 0.1% (Lotion) contains 1 mg mometasone furoate in a colorless, clear to translucent lotion base of hydroxypropyl cellulose, isopropyl alcohol 40% v/v, phosphoric acid, propylene glycol, purified water and sodium phosphate monobasic.</Description>
</NDC>
<NDC>
<NDCCode>53346-1305-5</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (53346-1305-5)</PackageDescription>
<NDC11Code>53346-1305-05</NDC11Code>
<ProductNDC>53346-1305</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr. Reckeweg R5 Gastreu</ProprietaryName>
<ProprietaryNameSuffix>Combination Product</ProprietaryNameSuffix>
<NonProprietaryName>Anacardium Orientale 6x, Argentum Nitricum 6x, Arsenicum Album 6x, Belladonna 4x, Carbo Vegetabilis 8x, Chamomilla 2x, Chelidonium Majus, Radix 3x, Lycopodium Clavatum 5x, Nux Vomica 4x, Scrophularia Nodosa 1x</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO</LabelerName>
<SubstanceName>SEMECARPUS ANACARDIUM FRUIT; SILVER NITRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CHELIDONIUM MAJUS ROOT; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; SCROPHULARIA NODOSA</SubstanceName>
<StrengthNumber>6; 6; 6; 4; 8; 2; 3; 5; 4; 1</StrengthNumber>
<StrengthUnit>[hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. For the temporary relief of.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57841-1201-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57841-1201-1) / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK (57841-1201-0) </PackageDescription>
<NDC11Code>57841-1201-01</NDC11Code>
<ProductNDC>57841-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aemcolo</ProprietaryName>
<NonProprietaryName>Rifamycin</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210910</ApplicationNumber>
<LabelerName>RedHill Biopharma Ltd</LabelerName>
<SubstanceName>RIFAMYCIN</SubstanceName>
<StrengthNumber>194</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AEMCOLO is a rifamycin antibacterial indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coliin adults. ( 1.1). Limitations of Use:. AEMCOLO is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.( 1, 5.1, 14). To reduce the development of drug-resistant bacteria and maintain the effectiveness of AEMCOLO and other antibacterial drugs, AEMCOLO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.2).</IndicationAndUsage>
<Description>AEMCOLO, delayed-release tablet, for oral administration, contains 194 mg of rifamycin equivalent to 200 mg of rifamycin sodium. Rifamycin sodium is a rifamycin antibacterial. It is designated chemically as: Sodium (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-21-(acetyloxy)-6,9,17,19-tetrahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1- b]furan-5-olate. Its empirical formula is C 37H 46NNaO 12. The molecular weight is 720 g/mol. Its structural formula is. Rifamycin sodium is a fine or slightly granular powder, soluble in water, and freely soluble in anhydrous ethanol. AEMCOLO, delayed-release tablets are enteric coated with a pH-resistant polymer film which breaks down above pH 7. The tablet core contains rifamycin. The tablets are yellow brown and ellipsoidal. Each tablet contains the following inactive ingredients: ammonio methacrylate copolymer (Type B), ascorbic acid, glyceryl distearate, lecithin, magnesium stearate, mannitol, methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol 6000, colloidal silicon dioxide, talc, titanium dioxide, triethylcitrate, yellow ferric oxide.</Description>
</NDC>
</NDCList>