{
"NDC": [
{
"NDCCode": "65649-303-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (65649-303-02) ",
"NDC11Code": "65649-0303-02",
"ProductNDC": "65649-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xifaxan",
"NonProprietaryName": "Rifaximin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021361",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "RIFAXIMIN",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100501",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "65649-303-01",
"PackageDescription": "3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK",
"NDC11Code": "65649-0303-01",
"ProductNDC": "65649-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xifaxan",
"NonProprietaryName": "Rifaximin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021361",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "RIFAXIMIN",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100501",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "65649-303-03",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "65649-0303-03",
"ProductNDC": "65649-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xifaxan",
"NonProprietaryName": "Rifaximin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021361",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "RIFAXIMIN",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100501",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "65649-303-04",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (65649-303-04) > 3 TABLET in 1 BLISTER PACK",
"NDC11Code": "65649-0303-04",
"ProductNDC": "65649-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xifaxan",
"NonProprietaryName": "Rifaximin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021361",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "RIFAXIMIN",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC],Rifamycins [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100501",
"EndMarketingDatePackage": "20200430",
"SamplePackage": "N"
},
{
"NDCCode": "65649-303-05",
"PackageDescription": "3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK",
"NDC11Code": "65649-0303-05",
"ProductNDC": "65649-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xifaxan",
"NonProprietaryName": "Rifaximin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021361",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "RIFAXIMIN",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Rifamycin Antibacterial [EPC], Rifamycins [CS]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100501",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide."
},
{
"NDCCode": "65649-101-02",
"PackageDescription": "280 CAPSULE in 1 BOTTLE (65649-101-02) ",
"NDC11Code": "65649-0101-02",
"ProductNDC": "65649-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colazal",
"NonProprietaryName": "Balsalazide Disodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000718",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020610",
"LabelerName": "Salix Pharmaceuticals, Inc",
"SubstanceName": "BALSALAZIDE DISODIUM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000718",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "COLAZAL ®is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use. Safety and effectiveness of COLAZAL beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established.",
"Description": "Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an aminosalicylate. Each capsule of COLAZAL (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is. Molecular Weight: 437.32. Molecular Formula: C 17H 13N 3O 6Na 2●2H 2O. Balsalazide disodium is a stable orange to yellow crystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents. Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg."
},
{
"NDCCode": "65649-102-02",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (65649-102-02) ",
"NDC11Code": "65649-0102-02",
"ProductNDC": "65649-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Giazo",
"NonProprietaryName": "Balsalazide Disodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120203",
"EndMarketingDate": "20200831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022205",
"LabelerName": "Salix Pharmaceuticals, Inc",
"SubstanceName": "BALSALAZIDE DISODIUM",
"StrengthNumber": "1.1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Aminosalicylate [EPC],Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120203",
"EndMarketingDatePackage": "20200831",
"SamplePackage": "N"
},
{
"NDCCode": "65649-103-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "65649-0103-02",
"ProductNDC": "65649-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apriso",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20081031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022301",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20081031",
"SamplePackage": "N",
"IndicationAndUsage": "APRISO ®is indicated for the maintenance of remission of ulcerative colitis in adults.",
"Description": "Each APRISO ®capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is:. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine."
},
{
"NDCCode": "65649-400-02",
"PackageDescription": "1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH",
"NDC11Code": "65649-0400-02",
"ProductNDC": "65649-400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plenvu",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate",
"DosageFormName": "KIT",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209381",
"LabelerName": "Salix Pharmaceuticals, Inc",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "Y",
"IndicationAndUsage": "PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.",
"Description": "The active ingredients contained in PLENVU are provided in Table 3. PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
},
{
"NDCCode": "65649-431-02",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65649-431-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "65649-0431-02",
"ProductNDC": "65649-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metozolv",
"ProprietaryNameSuffix": "Odt",
"NonProprietaryName": "Metoclopramide Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20090904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022246",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-05-17"
},
{
"NDCCode": "65649-432-02",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65649-432-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "65649-0432-02",
"ProductNDC": "65649-432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metozolv",
"ProprietaryNameSuffix": "Odt",
"NonProprietaryName": "Metoclopramide Hydrochloride",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20090904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022246",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METOCLOPRAMIDE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-05-17"
},
{
"NDCCode": "65649-551-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "65649-0551-02",
"ProductNDC": "65649-551",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relistor",
"NonProprietaryName": "Methylnaltrexone Bromide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20080424",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021964",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "METHYLNALTREXONE BROMIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/.6mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080424",
"SamplePackage": "N",
"IndicationAndUsage": "RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults 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. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .",
"Description": "RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride."
},
{
"NDCCode": "65649-651-03",
"PackageDescription": "2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02) ",
"NDC11Code": "65649-0651-03",
"ProductNDC": "65649-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uceris",
"NonProprietaryName": "Budesonide",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205613",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "BUDESONIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141201",
"SamplePackage": "N",
"IndicationAndUsage": "UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.",
"Description": "UCERIS rectal foam contains budesonide, a non-halogenated synthetic glucocorticoid, as the active ingredient. It is a mixture of the 2 epimers (22R and 22S) differing in the position of an acetal chain. Both epimers are active glucocorticoids applied in a mixture of approximately 1:1. Budesonide is designated chemically as (RS)-11β, 16α, 17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. UCERIS rectal foam contains 2 mg budesonide per metered dose. Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, emulsifying wax, polyoxyl (10) stearyl ether, propylene glycol, and purified water. Propellant: n-butane, isobutane, and propane."
},
{
"NDCCode": "65649-802-02",
"PackageDescription": "60 TABLET, COATED in 1 BOTTLE (65649-802-02)",
"NDC11Code": "65649-0802-02",
"ProductNDC": "65649-802",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fulyzaq",
"NonProprietaryName": "Crofelemer",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202292",
"LabelerName": "Salix Pharmaceuticals, Inc.",
"SubstanceName": "CROFELEMER",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antidiarrheal [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13537-303-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-303-02) > 4 g in 1 TUBE (13537-303-01)",
"NDC11Code": "13537-0303-02",
"ProductNDC": "13537-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Extreme Moisturizing Spf 16",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16030-303-02",
"PackageDescription": "2 mL in 1 SYRINGE, GLASS (16030-303-02) ",
"NDC11Code": "16030-0303-02",
"ProductNDC": "16030-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aurovisc Lubricant Hypromellose 2208 (15000 Mpa.s) Gel/drops",
"NonProprietaryName": "Hypromellose Ophthalmic Solution 2% W/v",
"DosageFormName": "SOLUTION, GEL FORMING / DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220926",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "Aurolab",
"SubstanceName": "HYPROMELLOSE 2208 (15000 MPA.S)",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220926",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N"
},
{
"NDCCode": "27808-303-02",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-02) ",
"NDC11Code": "27808-0303-02",
"ProductNDC": "27808-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Succinate",
"NonProprietaryName": "Metoprolol Succinate",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207206",
"LabelerName": "Cranbury Pharmaceuticals, LLC",
"SubstanceName": "METOPROLOL SUCCINATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"Description": "Metoprolol succinate, USP, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether, and heptane. Inactive ingredients: ethylcellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide."
},
{
"NDCCode": "29336-303-02",
"PackageDescription": "30 PATCH in 1 CARTON (29336-303-02) > 1 d in 1 PATCH",
"NDC11Code": "29336-0303-02",
"ProductNDC": "29336-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minitran",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089773",
"LabelerName": "Graceway Pharmaceuticals, LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.",
"Description": "Nitroglycerin is a 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The MINITRAN (nitroglycerin) Transdermal Delivery System is a unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm2 of applied system delivers approximately 0.03 mg of nitroglycerin per hour. Thus, the 3.3, 6.7, 13.3 and 20 cm2 system delivers approximately 0.1, 0.2, 0.4 and 0.6 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered about 14% of its original content of nitroglycerin. The MINITRAN Transdermal Delivery System contains nitroglycerin as the active component. The remaining components of the system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Each patch is packaged in foil/polymer film laminate. Prior to use, a protective peel strip is removed from the adhesive surface. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion by children or others."
},
{
"NDCCode": "37808-303-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (37808-303-02) > 24 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "37808-0303-02",
"ProductNDC": "37808-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ranitidine",
"NonProprietaryName": "Ranitidine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200172",
"LabelerName": "H-E-B",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20180125",
"SamplePackage": "N"
},
{
"NDCCode": "42677-303-02",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-303-02) ",
"NDC11Code": "42677-0303-02",
"ProductNDC": "42677-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207375",
"LabelerName": "Shandong New Time Pharmaceutical Co., Ltd.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.",
"Description": "Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: mannitol, meglumine, hypromellose, microcrystalline cellulose, crospovidone, magnesium stearate, HPMC 2910/hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin and iron oxide red."
},
{
"NDCCode": "42865-303-02",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-303-02) ",
"NDC11Code": "42865-0303-02",
"ProductNDC": "42865-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zenpep",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090922",
"EndMarketingDate": "20200131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022210",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE",
"StrengthNumber": "20000; 68000; 109000",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Deprecated",
"LastUpdate": "2020-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090922",
"EndMarketingDatePackage": "20200131",
"SamplePackage": "N"
},
{
"NDCCode": "49351-303-02",
"PackageDescription": "44 mL in 1 BOTTLE (49351-303-02) ",
"NDC11Code": "49351-0303-02",
"ProductNDC": "49351-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tork Hand Sanitizing Alcohol-free Foam",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221218",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Essity Professional Hygiene North America LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221218",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help decrease bacteria on the skin. Recommended for repeated use."
},
{
"NDCCode": "49738-303-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (49738-303-02) > 60 SPRAY, METERED in 1 BOTTLE",
"NDC11Code": "49738-0303-02",
"ProductNDC": "49738-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smart Sense Allergy Relief",
"NonProprietaryName": "Fluticasone Propionate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20160610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207957",
"LabelerName": "Kmart Corporation",
"SubstanceName": "FLUTICASONE PROPIONATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "49884-303-02",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (49884-303-02)",
"NDC11Code": "49884-0303-02",
"ProductNDC": "49884-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zafirlukast",
"NonProprietaryName": "Zafirlukast",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"EndMarketingDate": "20170831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020547",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "ZAFIRLUKAST",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-09-01"
},
{
"NDCCode": "49967-303-02",
"PackageDescription": "100 mL in 1 TUBE (49967-303-02) ",
"NDC11Code": "49967-0303-02",
"ProductNDC": "49967-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum Spf 25 Sunscreen",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "L'Oreal USA Products Inc",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "67; 115",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221212",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "50066-304-02",
"PackageDescription": "1 KIT in 1 CARTON (50066-304-02) * 1 BOTTLE, PLASTIC in 1 CARTON (50066-302-04) / 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "50066-0304-02",
"ProductNDC": "50066-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tukol Honey Daytime And Nighttime Value Pack",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Doxylamine Succinate",
"DosageFormName": "KIT",
"StartMarketingDate": "20230130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Genomma Lab USA",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230130",
"SamplePackage": "N"
},
{
"NDCCode": "50405-303-02",
"PackageDescription": "60 TABLET in 1 BOTTLE (50405-303-02) ",
"NDC11Code": "50405-0303-02",
"ProductNDC": "50405-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079042",
"LabelerName": "SOHM, Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240527",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)- a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water, soluble in acetonitrile, and practically insoluble in hexane. Levetiracetam Tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, corn starch, magnesium stearate, povidone, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: iron oxide yellow. 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red. Meets USP Dissolution Test 3."
},
{
"NDCCode": "51150-303-02",
"PackageDescription": "100 mL in 1 TUBE (51150-303-02) ",
"NDC11Code": "51150-0303-02",
"ProductNDC": "51150-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum Spf 25 Sunscreen",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221212",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SICOS ET CIE",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "67; 115",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221212",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "51706-303-02",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (51706-303-02) > 55 mL in 1 BOTTLE (51706-303-01)",
"NDC11Code": "51706-0303-02",
"ProductNDC": "51706-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bodycology",
"ProprietaryNameSuffix": "Moisturizing Hand Sanitizer Cucumber Melon",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Landy International",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions:. -Wet hands with product and allow to dry without wiping. -For children under 6, use only under adult supervision. -Not recommended for infants."
},
{
"NDCCode": "52125-303-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (52125-303-02)",
"NDC11Code": "52125-0303-02",
"ProductNDC": "52125-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077534",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-20"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>65649-303-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (65649-303-02) </PackageDescription>
<NDC11Code>65649-0303-02</NDC11Code>
<ProductNDC>65649-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xifaxan</ProprietaryName>
<NonProprietaryName>Rifaximin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021361</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIFAXIMIN</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65649-303-01</NDCCode>
<PackageDescription>3 CARTON in 1 TRAY (65649-303-01) / 1 BLISTER PACK in 1 CARTON / 2 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65649-0303-01</NDC11Code>
<ProductNDC>65649-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xifaxan</ProprietaryName>
<NonProprietaryName>Rifaximin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021361</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIFAXIMIN</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65649-303-03</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (65649-303-03) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65649-0303-03</NDC11Code>
<ProductNDC>65649-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xifaxan</ProprietaryName>
<NonProprietaryName>Rifaximin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021361</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIFAXIMIN</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65649-303-04</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (65649-303-04) > 3 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65649-0303-04</NDC11Code>
<ProductNDC>65649-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xifaxan</ProprietaryName>
<NonProprietaryName>Rifaximin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021361</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIFAXIMIN</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC],Rifamycins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100501</StartMarketingDatePackage>
<EndMarketingDatePackage>20200430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65649-303-05</NDCCode>
<PackageDescription>3 CARTON in 1 TRAY (65649-303-05) / 1 BLISTER PACK in 1 CARTON / 3 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65649-0303-05</NDC11Code>
<ProductNDC>65649-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xifaxan</ProprietaryName>
<NonProprietaryName>Rifaximin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021361</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>RIFAXIMIN</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Rifamycin Antibacterial [EPC], Rifamycins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-á]-benzimidazole-1,15(2H)-dione,25- acetate. The empirical formula is C43H51N3O11 and its molecular weight is 785.9. The chemical structure is represented below. XIFAXAN tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin. Inactive ingredients. Each 200 mg tablet contains colloidal silicon dioxide, disodium edetate, glycerol palmitostearate, hypromellose, microcrystalline cellulose, propylene glycol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide. Each 550 mg tablet contains colloidal silicon dioxide, glycerol palmitostearate, microcrystalline cellulose, polyethylene glycol/macrogol, polyvinyl alcohol, red iron oxide, sodium starch glycolate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>65649-101-02</NDCCode>
<PackageDescription>280 CAPSULE in 1 BOTTLE (65649-101-02) </PackageDescription>
<NDC11Code>65649-0101-02</NDC11Code>
<ProductNDC>65649-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colazal</ProprietaryName>
<NonProprietaryName>Balsalazide Disodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000718</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020610</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc</LabelerName>
<SubstanceName>BALSALAZIDE DISODIUM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000718</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COLAZAL ®is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Limitations of Use. Safety and effectiveness of COLAZAL beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established.</IndicationAndUsage>
<Description>Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an aminosalicylate. Each capsule of COLAZAL (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is. Molecular Weight: 437.32. Molecular Formula: C 17H 13N 3O 6Na 2●2H 2O. Balsalazide disodium is a stable orange to yellow crystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents. Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.</Description>
</NDC>
<NDC>
<NDCCode>65649-102-02</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (65649-102-02) </PackageDescription>
<NDC11Code>65649-0102-02</NDC11Code>
<ProductNDC>65649-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Giazo</ProprietaryName>
<NonProprietaryName>Balsalazide Disodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120203</StartMarketingDate>
<EndMarketingDate>20200831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022205</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc</LabelerName>
<SubstanceName>BALSALAZIDE DISODIUM</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC],Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120203</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65649-103-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65649-103-02) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>65649-0103-02</NDC11Code>
<ProductNDC>65649-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apriso</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081031</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022301</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APRISO ®is indicated for the maintenance of remission of ulcerative colitis in adults.</IndicationAndUsage>
<Description>Each APRISO ®capsule is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is:. Molecular Weight: 153.14. Molecular Formula: C 7H 7NO 3. Each APRISO capsule contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of APRISO capsules are: anhydrous citric acid, aspartame, colloidal silicon dioxide, edible black ink, hypromellose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone, simethicone emulsion, ethyl acrylate/methyl methacrylate copolymer, talc, titanium dioxide, triethyl citrate, vanilla flavor. Each APRISO 0.375 g capsule contains 0.56 mg of phenylalanine.</Description>
</NDC>
<NDC>
<NDCCode>65649-400-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (65649-400-02) * 46.26 POWDER, FOR SOLUTION in 1 POUCH * 55.65 POWDER, FOR SOLUTION in 1 POUCH * 115.96 POWDER, FOR SOLUTION in 1 POUCH</PackageDescription>
<NDC11Code>65649-0400-02</NDC11Code>
<ProductNDC>65649-400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plenvu</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Ascorbic Acid, Sodium Ascorbate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180504</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209381</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180504</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>PLENVU® is indicated for cleansing of the colon in preparation for colonoscopy in adults.</IndicationAndUsage>
<Description>The active ingredients contained in PLENVU are provided in Table 3. PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) is an osmotic laxative consisting of three pouches (one for Dose 1, one for Dose 2 Pouch A and one for Dose 2 Pouch B) containing white to yellow powder for reconstitution. Dose 1 contains 100 grams of PEG 3350, 9 grams of sodium sulfate, 2 grams of sodium chloride, and 1 gram of potassium chloride, and the following excipients: sucralose, encapsulated citric acid and mango flavoring. When Dose 1 is dissolved in water to a volume of 16 fluid ounces, PLENVU Dose 1 (PEG 3350, sodium sulfate, sodium chloride and potassium chloride) is an oral solution having a mango flavor. Each Dose 2 Pouch A contains 40 grams of PEG 3350, 3.2 grams of sodium chloride, and 1.2 grams of potassium chloride, and the following excipients: aspartame and fruit punch flavoring. Each Dose 2 Pouch B contains 48.11 grams of sodium ascorbate and 7.54 grams of ascorbic acid. When Dose 2 Pouch A and Dose 2 Pouch B are dissolved together in water to a volume of 16 fluid ounces, PLENVU Dose 2 (sodium ascorbate, PEG 3350, ascorbic acid, sodium chloride and potassium chloride) is an oral solution having a fruit punch flavor. The entire reconstituted 32 fluid ounces of PLENVU bowel preparation contains 140 grams of PEG 3350, 48.11 grams of sodium ascorbate, 9 grams of sodium sulfate, 7.54 grams of ascorbic acid, 5.2 grams of sodium chloride and 2.2 grams of potassium chloride and the following excipients: aspartame, sucralose, encapsulated citric acid, mango and fruit punch flavorings. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 491 mg per treatment. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
</NDC>
<NDC>
<NDCCode>65649-431-02</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65649-431-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65649-0431-02</NDC11Code>
<ProductNDC>65649-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metozolv</ProprietaryName>
<ProprietaryNameSuffix>Odt</ProprietaryNameSuffix>
<NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022246</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>65649-432-02</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65649-432-02) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65649-0432-02</NDC11Code>
<ProductNDC>65649-432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metozolv</ProprietaryName>
<ProprietaryNameSuffix>Odt</ProprietaryNameSuffix>
<NonProprietaryName>Metoclopramide Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022246</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METOCLOPRAMIDE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine D2 Antagonists [MoA],Dopamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>65649-551-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>65649-0551-02</NDC11Code>
<ProductNDC>65649-551</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relistor</ProprietaryName>
<NonProprietaryName>Methylnaltrexone Bromide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20080424</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021964</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHYLNALTREXONE BROMIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/.6mL</StrengthUnit>
<Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA], Quaternary Ammonium Compounds [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults 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. (1.1) . RELISTOR injection is indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (1.2) .</IndicationAndUsage>
<Description>RELISTOR® (methylnaltrexone bromide) is a mu-opioid receptor antagonist. The chemical name for methylnaltrexone bromide is (R)-N-(cyclopropylmethyl) noroxymorphone methobromide. The molecular formula is C21H26NO4Br, and the molecular weight is 436.36. The structural formula is. RELISTOR tablets for oral administration are film-coated and contain 150 mg of methylnaltrexone bromide (equivalent to 122.5 mg methylnaltrexone). Inactive ingredients are silicified microcrystalline cellulose, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, crospovidone, poloxamer 407, stearic acid (vegetable source), colloidal silicon dioxide, edetate calcium disodium, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. RELISTOR for subcutaneous administration is a sterile, clear and colorless to pale yellow aqueous solution. Each 3 mL vial contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride. During manufacture, the pH may have been adjusted with hydrochloric acid and/or sodium hydroxide. Each 8 mg/0.4 mL pre-filled syringe (1 mL syringe) contains 8 mg of methylnaltrexone bromide (equivalent to 6.5 mg of methylnaltrexone) in 0.4 mL of water. The excipients are 2.6 mg sodium chloride USP, 0.16 mg edetate calcium disodium USP, and 0.12 mg glycine hydrochloride. Each 12 mg/0.6 mL pre-filled syringe (1 mL syringe) contains 12 mg of methylnaltrexone bromide (equivalent to 9.8 mg of methylnaltrexone) in 0.6 mL of water. The excipients are 3.9 mg sodium chloride USP, 0.24 mg edetate calcium disodium USP, and 0.18 mg glycine hydrochloride.</Description>
</NDC>
<NDC>
<NDCCode>65649-651-03</NDCCode>
<PackageDescription>2 CANISTER in 1 CARTON (65649-651-03) / 1 AEROSOL, FOAM in 1 CANISTER (65649-651-02) </PackageDescription>
<NDC11Code>65649-0651-03</NDC11Code>
<ProductNDC>65649-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uceris</ProprietaryName>
<NonProprietaryName>Budesonide</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205613</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BUDESONIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.</IndicationAndUsage>
<Description>UCERIS rectal foam contains budesonide, a non-halogenated synthetic glucocorticoid, as the active ingredient. It is a mixture of the 2 epimers (22R and 22S) differing in the position of an acetal chain. Both epimers are active glucocorticoids applied in a mixture of approximately 1:1. Budesonide is designated chemically as (RS)-11β, 16α, 17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is. UCERIS rectal foam contains 2 mg budesonide per metered dose. Inactive ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, emulsifying wax, polyoxyl (10) stearyl ether, propylene glycol, and purified water. Propellant: n-butane, isobutane, and propane.</Description>
</NDC>
<NDC>
<NDCCode>65649-802-02</NDCCode>
<PackageDescription>60 TABLET, COATED in 1 BOTTLE (65649-802-02)</PackageDescription>
<NDC11Code>65649-0802-02</NDC11Code>
<ProductNDC>65649-802</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fulyzaq</ProprietaryName>
<NonProprietaryName>Crofelemer</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202292</ApplicationNumber>
<LabelerName>Salix Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CROFELEMER</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13537-303-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-303-02) > 4 g in 1 TUBE (13537-303-01)</PackageDescription>
<NDC11Code>13537-0303-02</NDC11Code>
<ProductNDC>13537-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Extreme Moisturizing Spf 16</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16030-303-02</NDCCode>
<PackageDescription>2 mL in 1 SYRINGE, GLASS (16030-303-02) </PackageDescription>
<NDC11Code>16030-0303-02</NDC11Code>
<ProductNDC>16030-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aurovisc Lubricant Hypromellose 2208 (15000 Mpa.s) Gel/drops</ProprietaryName>
<NonProprietaryName>Hypromellose Ophthalmic Solution 2% W/v</NonProprietaryName>
<DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220926</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>Aurolab</LabelerName>
<SubstanceName>HYPROMELLOSE 2208 (15000 MPA.S)</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220926</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>27808-303-02</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-303-02) </PackageDescription>
<NDC11Code>27808-0303-02</NDC11Code>
<ProductNDC>27808-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Succinate</ProprietaryName>
<NonProprietaryName>Metoprolol Succinate</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207206</ApplicationNumber>
<LabelerName>Cranbury Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METOPROLOL SUCCINATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Metoprolol succinate, USP, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended-release tablets. Metoprolol succinate extended-release tablets, USP have been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate, USP equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1- (isopropyl amino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is. Metoprolol succinate, USP is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl acetate, acetone, diethyl ether, and heptane. Inactive ingredients: ethylcellulose, hypromellose type 2208, hypromellose type 2910, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>29336-303-02</NDCCode>
<PackageDescription>30 PATCH in 1 CARTON (29336-303-02) > 1 d in 1 PATCH</PackageDescription>
<NDC11Code>29336-0303-02</NDC11Code>
<ProductNDC>29336-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minitran</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089773</ApplicationNumber>
<LabelerName>Graceway Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack.</IndicationAndUsage>
<Description>Nitroglycerin is a 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is. and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins. The MINITRAN (nitroglycerin) Transdermal Delivery System is a unit designed to provide continuous controlled release of nitroglycerin through intact skin. The rate of release of nitroglycerin is linearly dependent upon the area of the applied system; each cm2 of applied system delivers approximately 0.03 mg of nitroglycerin per hour. Thus, the 3.3, 6.7, 13.3 and 20 cm2 system delivers approximately 0.1, 0.2, 0.4 and 0.6 mg of nitroglycerin per hour, respectively. The remainder of the nitroglycerin in each system serves as a reservoir and is not delivered in normal use. After 12 hours, for example, each system has delivered about 14% of its original content of nitroglycerin. The MINITRAN Transdermal Delivery System contains nitroglycerin as the active component. The remaining components of the system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Each patch is packaged in foil/polymer film laminate. Prior to use, a protective peel strip is removed from the adhesive surface. Following use, the patch should be discarded in a manner that prevents accidental application or ingestion by children or others.</Description>
</NDC>
<NDC>
<NDCCode>37808-303-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (37808-303-02) > 24 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>37808-0303-02</NDC11Code>
<ProductNDC>37808-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ranitidine</ProprietaryName>
<NonProprietaryName>Ranitidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200172</ApplicationNumber>
<LabelerName>H-E-B</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42677-303-02</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-303-02) </PackageDescription>
<NDC11Code>42677-0303-02</NDC11Code>
<ProductNDC>42677-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207375</ApplicationNumber>
<LabelerName>Shandong New Time Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor., 2 As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The empirical formula for rosuvastatin calcium, USP is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: Each tablet contains: mannitol, meglumine, hypromellose, microcrystalline cellulose, crospovidone, magnesium stearate, HPMC 2910/hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin and iron oxide red.</Description>
</NDC>
<NDC>
<NDCCode>42865-303-02</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42865-303-02) </PackageDescription>
<NDC11Code>42865-0303-02</NDC11Code>
<ProductNDC>42865-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zenpep</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090922</StartMarketingDate>
<EndMarketingDate>20200131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022210</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE; PANCRELIPASE AMYLASE</SubstanceName>
<StrengthNumber>20000; 68000; 109000</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090922</StartMarketingDatePackage>
<EndMarketingDatePackage>20200131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49351-303-02</NDCCode>
<PackageDescription>44 mL in 1 BOTTLE (49351-303-02) </PackageDescription>
<NDC11Code>49351-0303-02</NDC11Code>
<ProductNDC>49351-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tork Hand Sanitizing Alcohol-free Foam</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221218</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Essity Professional Hygiene North America LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help decrease bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49738-303-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49738-303-02) > 60 SPRAY, METERED in 1 BOTTLE</PackageDescription>
<NDC11Code>49738-0303-02</NDC11Code>
<ProductNDC>49738-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smart Sense Allergy Relief</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207957</ApplicationNumber>
<LabelerName>Kmart Corporation</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49884-303-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (49884-303-02)</PackageDescription>
<NDC11Code>49884-0303-02</NDC11Code>
<ProductNDC>49884-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zafirlukast</ProprietaryName>
<NonProprietaryName>Zafirlukast</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<EndMarketingDate>20170831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020547</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>ZAFIRLUKAST</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA],Cytochrome P450 2C9 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>49967-303-02</NDCCode>
<PackageDescription>100 mL in 1 TUBE (49967-303-02) </PackageDescription>
<NDC11Code>49967-0303-02</NDC11Code>
<ProductNDC>49967-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum Spf 25 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>L'Oreal USA Products Inc</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>67; 115</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50066-304-02</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (50066-304-02) * 1 BOTTLE, PLASTIC in 1 CARTON (50066-302-04) / 118 mL in 1 BOTTLE, PLASTIC * 1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>50066-0304-02</NDC11Code>
<ProductNDC>50066-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tukol Honey Daytime And Nighttime Value Pack</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230130</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Genomma Lab USA</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50405-303-02</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50405-303-02) </PackageDescription>
<NDC11Code>50405-0303-02</NDC11Code>
<ProductNDC>50405-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079042</ApplicationNumber>
<LabelerName>SOHM, Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: 1 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2), 2 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)- a-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water, soluble in acetonitrile, and practically insoluble in hexane. Levetiracetam Tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, corn starch, magnesium stearate, povidone, polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake. 500 mg tablets: iron oxide yellow. 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>51150-303-02</NDCCode>
<PackageDescription>100 mL in 1 TUBE (51150-303-02) </PackageDescription>
<NDC11Code>51150-0303-02</NDC11Code>
<ProductNDC>51150-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum Spf 25 Sunscreen</ProprietaryName>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221212</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SICOS ET CIE</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>67; 115</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51706-303-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (51706-303-02) > 55 mL in 1 BOTTLE (51706-303-01)</PackageDescription>
<NDC11Code>51706-0303-02</NDC11Code>
<ProductNDC>51706-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bodycology</ProprietaryName>
<ProprietaryNameSuffix>Moisturizing Hand Sanitizer Cucumber Melon</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Landy International</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions:. -Wet hands with product and allow to dry without wiping. -For children under 6, use only under adult supervision. -Not recommended for infants.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52125-303-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (52125-303-02)</PackageDescription>
<NDC11Code>52125-0303-02</NDC11Code>
<ProductNDC>52125-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077534</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-02-20</LastUpdate>
</NDC>
</NDCList>