{
"NDC": [
{
"NDCCode": "35000-082-08",
"PackageDescription": "258 mL in 1 BOTTLE (35000-082-08) ",
"NDC11Code": "35000-0082-08",
"ProductNDC": "35000-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Softsoap Antibacterial Foaming Hand Crisp Clean",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.33",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N"
},
{
"NDCCode": "35000-068-08",
"PackageDescription": "8 CARTON in 1 CELLO PACK (35000-068-08) / 1 APPLICATOR in 1 CARTON / 104.8 g in 1 APPLICATOR",
"NDC11Code": "35000-0068-08",
"ProductNDC": "35000-068",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Irish Spring Antibacterial Bar",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "helps eliminate bacteria on skin."
},
{
"NDCCode": "35000-083-08",
"PackageDescription": "258 mL in 1 BOTTLE (35000-083-08) ",
"NDC11Code": "35000-0083-08",
"ProductNDC": "35000-083",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Softsoap Antibacterial Foaming Hand Kitchen Fresh Hands Zesty Lemon",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.33",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N"
},
{
"NDCCode": "16714-082-08",
"PackageDescription": "60 TABLET in 1 BOTTLE (16714-082-08)",
"NDC11Code": "16714-0082-08",
"ProductNDC": "16714-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20091111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040842",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "HYDROXYZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "37808-082-08",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (37808-082-08)",
"NDC11Code": "37808-0082-08",
"ProductNDC": "37808-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orchid By H E B",
"ProprietaryNameSuffix": "Cactus Flower And Mango Antibacterial Gentle Foaming Hand",
"NonProprietaryName": "Triclosan",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "H E B",
"SubstanceName": "TRICLOSAN",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "TO HELP REDUCE BACTERIA ON THE SKIN."
},
{
"NDCCode": "42794-082-08",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42794-082-08)",
"NDC11Code": "42794-0082-08",
"ProductNDC": "42794-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acitretin",
"NonProprietaryName": "Acitretin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204633",
"LabelerName": "Sigmapharm Laboratories, LLC",
"SubstanceName": "ACITRETIN",
"StrengthNumber": "22.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Retinoid [EPC],Retinoids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "71919-082-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-082-08) ",
"NDC11Code": "71919-0082-08",
"ProductNDC": "71919-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Montana, Radix",
"NonProprietaryName": "Arnica Montana Root",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20101011",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARNICA MONTANA ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101011",
"SamplePackage": "N"
},
{
"NDCCode": "77135-082-08",
"PackageDescription": "236.58 mL in 1 BOTTLE (77135-082-08) ",
"NDC11Code": "77135-0082-08",
"ProductNDC": "77135-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Carolina Hemp Refinery",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "36800-082-63",
"PackageDescription": "25 TABLET, CHEWABLE in 1 BOTTLE (36800-082-63) ",
"NDC11Code": "36800-0082-63",
"ProductNDC": "36800-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Dual Action Complete",
"NonProprietaryName": "Famotidine, Calcium Carbonate, Magnesium Hydroxide",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077355",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE",
"StrengthNumber": "10; 800; 165",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160229",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach."
},
{
"NDCCode": "36800-082-71",
"PackageDescription": "50 TABLET, CHEWABLE in 1 BOTTLE (36800-082-71) ",
"NDC11Code": "36800-0082-71",
"ProductNDC": "36800-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Dual Action Complete",
"NonProprietaryName": "Famotidine, Calcium Carbonate, Magnesium Hydroxide",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077355",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE",
"StrengthNumber": "800; 10; 165",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160229",
"SamplePackage": "N",
"IndicationAndUsage": "relieves heartburn associated with acid indigestion and sour stomach."
},
{
"NDCCode": "49873-082-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (49873-082-01) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "49873-0082-01",
"ProductNDC": "49873-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ringl",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19960509",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Sato Pharmaceutical Co., Ltd.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2023-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960509",
"SamplePackage": "N",
"IndicationAndUsage": "Uses■ for the temporary relief of minor aches and pains associated with: ■ a cold ■ sore throat ■ headache ■ toothache ■ muscular aches ■ backache ■ the premenstrual and menstrual periods (dysmenorrhea) ■ for minor pain from arthritis ■ to reduce fever."
},
{
"NDCCode": "50242-082-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-082-01) > .05 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0082-01",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120810",
"SamplePackage": "N"
},
{
"NDCCode": "50242-082-02",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-082-02) > .05 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0082-02",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20161128",
"SamplePackage": "N"
},
{
"NDCCode": "50242-082-87",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (50242-082-87) > .05 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "50242-0082-87",
"ProductNDC": "50242-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lucentis",
"NonProprietaryName": "Ranibizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVITREAL",
"StartMarketingDate": "20120810",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125156",
"LabelerName": "Genentech, Inc.",
"SubstanceName": "RANIBIZUMAB",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170228",
"SamplePackage": "Y"
},
{
"NDCCode": "51407-082-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (51407-082-01) ",
"NDC11Code": "51407-0082-01",
"ProductNDC": "51407-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200205",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210425",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200724",
"EndMarketingDatePackage": "20271231",
"SamplePackage": "N",
"IndicationAndUsage": "Colchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).",
"Description": "Colchicine is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[alpha]heptalen-7-yl) acetamide with a molecular formula of C 22H 25NO 6and a molecular weight of 399.4. The structural formula of colchicine is given below:. Colchicine occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” X 0.3030”), debossed with “G 02” on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "51407-082-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51407-082-30) ",
"NDC11Code": "51407-0082-30",
"ProductNDC": "51407-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200205",
"EndMarketingDate": "20271231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210425",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200724",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Colchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).",
"Description": "Colchicine is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[alpha]heptalen-7-yl) acetamide with a molecular formula of C 22H 25NO 6and a molecular weight of 399.4. The structural formula of colchicine is given below:. Colchicine occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” X 0.3030”), debossed with “G 02” on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin."
},
{
"NDCCode": "52544-082-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01) ",
"NDC11Code": "52544-0082-01",
"ProductNDC": "52544-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fioricet With Codeine",
"NonProprietaryName": "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130729",
"EndMarketingDate": "20260930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076560",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE",
"StrengthNumber": "50; 300; 40; 30",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130729",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve FIORICET with CODEINE for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "FIORICET with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) is supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP…………..........50 mg. Acetaminophen, USP………...300 mg. Caffeine, USP……………........40 mg. Codeine phosphate, USP….......30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. Inactive Ingredients: FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide."
},
{
"NDCCode": "53145-082-03",
"PackageDescription": "86 g in 1 JAR (53145-082-03) ",
"NDC11Code": "53145-0082-03",
"ProductNDC": "53145-082",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mascura La Vaca Plus",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190619",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "MENPER DISTRIBUTORS, INC.",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "10.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190619",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains."
},
{
"NDCCode": "55289-082-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (55289-082-01) ",
"NDC11Code": "55289-0082-01",
"ProductNDC": "55289-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076187",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100118",
"SamplePackage": "N"
},
{
"NDCCode": "55289-082-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (55289-082-30) ",
"NDC11Code": "55289-0082-30",
"ProductNDC": "55289-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076187",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100118",
"SamplePackage": "N"
},
{
"NDCCode": "55289-082-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (55289-082-90) ",
"NDC11Code": "55289-0082-90",
"ProductNDC": "55289-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20021101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076187",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100118",
"SamplePackage": "N"
},
{
"NDCCode": "59148-082-13",
"PackageDescription": "1 BOTTLE in 1 CARTON (59148-082-13) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "59148-0082-13",
"ProductNDC": "59148-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jynarque",
"NonProprietaryName": "Tolvaptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180423",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204441",
"LabelerName": "Otsuka America Pharmaceutical, Inc.",
"SubstanceName": "TOLVAPTAN",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180423",
"SamplePackage": "N",
"IndicationAndUsage": "JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).",
"Description": "JYNARQUE contains tolvaptan, a selective vasopressin V2-receptor antagonist in immediate release tablets for oral administration available in 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strengths. Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-o-tolu-m-toluidide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.94. The chemical structure is. Inactive ingredients include corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose and FD&C Blue No. 2 Aluminum Lake as colorant."
},
{
"NDCCode": "62135-082-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (62135-082-01) ",
"NDC11Code": "62135-0082-01",
"ProductNDC": "62135-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "62135-082-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (62135-082-30) ",
"NDC11Code": "62135-0082-30",
"ProductNDC": "62135-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "62135-082-31",
"PackageDescription": "300 CAPSULE in 1 BOTTLE (62135-082-31) ",
"NDC11Code": "62135-0082-31",
"ProductNDC": "62135-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA061926",
"LabelerName": "Chartwell RX, LLC",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260716",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .",
"Description": "Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide."
},
{
"NDCCode": "65862-082-18",
"PackageDescription": "1800 TABLET, FILM COATED in 1 BAG (65862-082-18) ",
"NDC11Code": "65862-0082-18",
"ProductNDC": "65862-082",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Glyburide And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20071114",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "GLYBURIDE; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-05-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "14-NOV-07"
},
{
"NDCCode": "66993-082-69",
"PackageDescription": "6 CONTAINER in 1 BOX (66993-082-69) / 100 uL in 1 CONTAINER",
"NDC11Code": "66993-0082-69",
"ProductNDC": "66993-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan",
"NonProprietaryName": "Sumatriptan",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20200701",
"EndMarketingDate": "20270731",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020626",
"LabelerName": "Prasco Laboratories",
"SubstanceName": "SUMATRIPTAN",
"StrengthNumber": "20",
"StrengthUnit": "mg/100uL",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200701",
"EndMarketingDatePackage": "20270731",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks., 2 Sumatriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of Sumatriptan Nasal Spray have not been established for cluster headache.",
"Description": "Sumatriptan Nasal Spray contains sumatriptan, a selective 5-HT1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure. The empirical formula is C14H21N3O2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline. Each Sumatriptan Nasal Spray contains 5 or 20 mg of sumatriptan in a 100-mcL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and purified water USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg Sumatriptan Nasal Spray, respectively."
},
{
"NDCCode": "67457-994-05",
"PackageDescription": "1 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE",
"NDC11Code": "67457-0994-05",
"ProductNDC": "67457-994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Regadenoson",
"NonProprietaryName": "Regadenoson",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230921",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213856",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "REGADENOSON",
"StrengthNumber": ".4",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230921",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.",
"Description": "Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology (12.1)]. Regadenoson is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, hemihydrate. Its structural formula is. The molecular formula for regadenoson hemihydrate is C15H18N8O5 ½H2O and its molecular weight is 399.35. Regadenoson is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains 0.082 mg of regadenoson hemihydrate, corresponding to 0.08 mg regadenoson on an anhydrous basis, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7."
},
{
"NDCCode": "71085-082-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (71085-082-30) ",
"NDC11Code": "71085-0082-30",
"ProductNDC": "71085-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurbiro",
"NonProprietaryName": "Flurbiprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074431",
"LabelerName": "IPG Pharmaceuticals, Inc.",
"SubstanceName": "FLURBIPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250801",
"SamplePackage": "N",
"IndicationAndUsage": "Flurbiprofen tablets are indicated: 1 For relief of the signs and symptoms of rheumatoid arthritis., 2 For relief of the signs and symptoms of osteoarthritis.",
"Description": "Flurbiprofen Tablets, USP are a member of the phenylalkanoic acid derivative group of nonsteroidal anti-inflammatory drug. Flurbiprofen Tablets, USP are round, blue, film-coated debossed \"NH\" – \"100\" tablets for oral administration. Flurbiprofen, USP is a racemic mixture of (+)S- and (-)R- enantiomers. Flurbiprofen, USP is a white or slightly yellow crystalline powder. It is slightly soluble in water at pH 7.0 and readily soluble in most polar solvents. The chemical name is [1,1'-biphenyl]-4-acetic acid, 2-fluoro-α-methyl-, (±)-. It has the following structural formula. C15H13FO2 M.W. 244.26. Each tablet, for oral administration, contains 100 mg flurbiprofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and FD&C Blue #1 aluminum lake."
},
{
"NDCCode": "72578-082-01",
"PackageDescription": "1 TUBE in 1 CARTON (72578-082-01) > 15 g in 1 TUBE",
"NDC11Code": "72578-0082-01",
"ProductNDC": "72578-082",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205974",
"LabelerName": "Viona Pharmaceuticals Inc",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2022-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200608",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.",
"Description": "Acyclovir Ointment USP, 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white to off-white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>35000-082-08</NDCCode>
<PackageDescription>258 mL in 1 BOTTLE (35000-082-08) </PackageDescription>
<NDC11Code>35000-0082-08</NDC11Code>
<ProductNDC>35000-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Softsoap Antibacterial Foaming Hand Crisp Clean</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.33</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>35000-068-08</NDCCode>
<PackageDescription>8 CARTON in 1 CELLO PACK (35000-068-08) / 1 APPLICATOR in 1 CARTON / 104.8 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>35000-0068-08</NDC11Code>
<ProductNDC>35000-068</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Irish Spring Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps eliminate bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35000-083-08</NDCCode>
<PackageDescription>258 mL in 1 BOTTLE (35000-083-08) </PackageDescription>
<NDC11Code>35000-0083-08</NDC11Code>
<ProductNDC>35000-083</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Softsoap Antibacterial Foaming Hand Kitchen Fresh Hands Zesty Lemon</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.33</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-082-08</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (16714-082-08)</PackageDescription>
<NDC11Code>16714-0082-08</NDC11Code>
<ProductNDC>16714-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040842</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>HYDROXYZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>37808-082-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (37808-082-08)</PackageDescription>
<NDC11Code>37808-0082-08</NDC11Code>
<ProductNDC>37808-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orchid By H E B</ProprietaryName>
<ProprietaryNameSuffix>Cactus Flower And Mango Antibacterial Gentle Foaming Hand</ProprietaryNameSuffix>
<NonProprietaryName>Triclosan</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>H E B</LabelerName>
<SubstanceName>TRICLOSAN</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TO HELP REDUCE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42794-082-08</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42794-082-08)</PackageDescription>
<NDC11Code>42794-0082-08</NDC11Code>
<ProductNDC>42794-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acitretin</ProprietaryName>
<NonProprietaryName>Acitretin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204633</ApplicationNumber>
<LabelerName>Sigmapharm Laboratories, LLC</LabelerName>
<SubstanceName>ACITRETIN</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>71919-082-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-082-08) </PackageDescription>
<NDC11Code>71919-0082-08</NDC11Code>
<ProductNDC>71919-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Montana, Radix</ProprietaryName>
<NonProprietaryName>Arnica Montana Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>77135-082-08</NDCCode>
<PackageDescription>236.58 mL in 1 BOTTLE (77135-082-08) </PackageDescription>
<NDC11Code>77135-0082-08</NDC11Code>
<ProductNDC>77135-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Carolina Hemp Refinery</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-082-63</NDCCode>
<PackageDescription>25 TABLET, CHEWABLE in 1 BOTTLE (36800-082-63) </PackageDescription>
<NDC11Code>36800-0082-63</NDC11Code>
<ProductNDC>36800-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Dual Action Complete</ProprietaryName>
<NonProprietaryName>Famotidine, Calcium Carbonate, Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077355</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>FAMOTIDINE; CALCIUM CARBONATE; MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>10; 800; 165</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36800-082-71</NDCCode>
<PackageDescription>50 TABLET, CHEWABLE in 1 BOTTLE (36800-082-71) </PackageDescription>
<NDC11Code>36800-0082-71</NDC11Code>
<ProductNDC>36800-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Dual Action Complete</ProprietaryName>
<NonProprietaryName>Famotidine, Calcium Carbonate, Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077355</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>800; 10; 165</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves heartburn associated with acid indigestion and sour stomach.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49873-082-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (49873-082-01) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>49873-0082-01</NDC11Code>
<ProductNDC>49873-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ringl</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Sato Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses■ for the temporary relief of minor aches and pains associated with: ■ a cold ■ sore throat ■ headache ■ toothache ■ muscular aches ■ backache ■ the premenstrual and menstrual periods (dysmenorrhea) ■ for minor pain from arthritis ■ to reduce fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50242-082-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-082-01) > .05 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0082-01</NDC11Code>
<ProductNDC>50242-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lucentis</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125156</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RANIBIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120810</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-082-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-082-02) > .05 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0082-02</NDC11Code>
<ProductNDC>50242-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lucentis</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125156</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RANIBIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50242-082-87</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (50242-082-87) > .05 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>50242-0082-87</NDC11Code>
<ProductNDC>50242-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lucentis</ProprietaryName>
<NonProprietaryName>Ranibizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVITREAL</RouteName>
<StartMarketingDate>20120810</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125156</ApplicationNumber>
<LabelerName>Genentech, Inc.</LabelerName>
<SubstanceName>RANIBIZUMAB</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170228</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-082-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (51407-082-01) </PackageDescription>
<NDC11Code>51407-0082-01</NDC11Code>
<ProductNDC>51407-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colchicine</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200205</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210425</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<EndMarketingDatePackage>20271231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).</IndicationAndUsage>
<Description>Colchicine is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[alpha]heptalen-7-yl) acetamide with a molecular formula of C 22H 25NO 6and a molecular weight of 399.4. The structural formula of colchicine is given below:. Colchicine occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” X 0.3030”), debossed with “G 02” on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>51407-082-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51407-082-30) </PackageDescription>
<NDC11Code>51407-0082-30</NDC11Code>
<ProductNDC>51407-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colchicine</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200205</StartMarketingDate>
<EndMarketingDate>20271231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210425</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200724</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colchicine is an alkaloid indicated for: Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2).</IndicationAndUsage>
<Description>Colchicine is an alkaloid chemically described as (S)N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[alpha]heptalen-7-yl) acetamide with a molecular formula of C 22H 25NO 6and a molecular weight of 399.4. The structural formula of colchicine is given below:. Colchicine occurs as a pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as purple, film-coated, capsule-shaped tablets (0.1575” X 0.3030”), debossed with “G 02” on one side and scored on the other, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: FD&C blue #2, FD&C red #40, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>52544-082-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (52544-082-01) </PackageDescription>
<NDC11Code>52544-0082-01</NDC11Code>
<ProductNDC>52544-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fioricet With Codeine</ProprietaryName>
<NonProprietaryName>Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130729</StartMarketingDate>
<EndMarketingDate>20260930</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076560</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>50; 300; 40; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130729</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FIORICET with CODEINE is indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve FIORICET with CODEINE for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>FIORICET with CODEINE (butalbital, acetaminophen, caffeine, and codeine phosphate) is supplied in capsule form for oral administration. Each capsule contains. Butalbital, USP…………..........50 mg. Acetaminophen, USP………...300 mg. Caffeine, USP……………........40 mg. Codeine phosphate, USP….......30 mg. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula. Acetaminophen (4'hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula. Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula. Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula. Inactive Ingredients: FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, microcrystalline cellulose, stearic acid, sodium lauryl sulfate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>53145-082-03</NDCCode>
<PackageDescription>86 g in 1 JAR (53145-082-03) </PackageDescription>
<NDC11Code>53145-0082-03</NDC11Code>
<ProductNDC>53145-082</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mascura La Vaca Plus</ProprietaryName>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>MENPER DISTRIBUTORS, INC.</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55289-082-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (55289-082-01) </PackageDescription>
<NDC11Code>55289-0082-01</NDC11Code>
<ProductNDC>55289-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076187</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55289-082-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (55289-082-30) </PackageDescription>
<NDC11Code>55289-0082-30</NDC11Code>
<ProductNDC>55289-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076187</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55289-082-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (55289-082-90) </PackageDescription>
<NDC11Code>55289-0082-90</NDC11Code>
<ProductNDC>55289-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076187</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59148-082-13</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59148-082-13) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>59148-0082-13</NDC11Code>
<ProductNDC>59148-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jynarque</ProprietaryName>
<NonProprietaryName>Tolvaptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180423</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204441</ApplicationNumber>
<LabelerName>Otsuka America Pharmaceutical, Inc.</LabelerName>
<SubstanceName>TOLVAPTAN</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).</IndicationAndUsage>
<Description>JYNARQUE contains tolvaptan, a selective vasopressin V2-receptor antagonist in immediate release tablets for oral administration available in 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strengths. Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-o-tolu-m-toluidide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.94. The chemical structure is. Inactive ingredients include corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose and FD&C Blue No. 2 Aluminum Lake as colorant.</Description>
</NDC>
<NDC>
<NDCCode>62135-082-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (62135-082-01) </PackageDescription>
<NDC11Code>62135-0082-01</NDC11Code>
<ProductNDC>62135-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-082-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (62135-082-30) </PackageDescription>
<NDC11Code>62135-0082-30</NDC11Code>
<ProductNDC>62135-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>62135-082-31</NDCCode>
<PackageDescription>300 CAPSULE in 1 BOTTLE (62135-082-31) </PackageDescription>
<NDC11Code>62135-0082-31</NDC11Code>
<ProductNDC>62135-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA061926</ApplicationNumber>
<LabelerName>Chartwell RX, LLC</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. : 1 Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. , 2 Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. , 3 Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli. , 4 Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae. .</IndicationAndUsage>
<Description>Amoxicillin, USP is a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin, USP molecular formula is C 16H 19N3O 5S3H 2O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg of amoxicillin, USP as the trihydrate. Each film-coated tablet contains: colloidal silicon dioxide, crospovidone, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, titanium dioxide and triacetin. For Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg of amoxicillin, USP as the trihydrate. Each 5 mL of the 125 mg reconstituted suspension contains 0.10 mEq (2.29 mg) of sodium. Each 5 mL of the 200 mg reconstituted suspension contains 0.09 mEq (2.11 mg) of sodium. Each 5 mL of the 250 mg reconstituted suspension contains 0.14 mEq (3.24 mg) of sodium. Each 5 mL of the 400 mg reconstituted suspension contains 0.12 mEq (2.69 mg) of sodium. Inactive ingredients for 200 mg and 400 mg: Colloidal silicon dioxide, FD&C Red No. 40, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, sucrose, and xanthan gum. Inactive ingredients for 125 mg and 250 mg: FD&C Red No. 40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Tablets (Chewable): Each tablet contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose. Capsules: Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate. The capsules contain the following inactive ingredients: magnesium stearate and talc. The capsule shell contains D&C Yellow No. 10, FD&C Red No. 40, gelatin, and titanium dioxide. In addition, the 250 mg contains D&C Red No. 28 and FD&C Blue No. 1. The 500 mg may also contain methylparaben, propylparaben, and sodium lauryl sulfate. The printing ink contains black iron oxide, propylene glycol, shellac, and strong ammonia solution. In addition, the 250 mg may contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Red No. 40 Aluminum Lake. The 500 mg may also contain potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>65862-082-18</NDCCode>
<PackageDescription>1800 TABLET, FILM COATED in 1 BAG (65862-082-18) </PackageDescription>
<NDC11Code>65862-0082-18</NDC11Code>
<ProductNDC>65862-082</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Glyburide And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20071114</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>GLYBURIDE; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-05-08</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>14-NOV-07</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66993-082-69</NDCCode>
<PackageDescription>6 CONTAINER in 1 BOX (66993-082-69) / 100 uL in 1 CONTAINER</PackageDescription>
<NDC11Code>66993-0082-69</NDC11Code>
<ProductNDC>66993-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan</ProprietaryName>
<NonProprietaryName>Sumatriptan</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20200701</StartMarketingDate>
<EndMarketingDate>20270731</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020626</ApplicationNumber>
<LabelerName>Prasco Laboratories</LabelerName>
<SubstanceName>SUMATRIPTAN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/100uL</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200701</StartMarketingDatePackage>
<EndMarketingDatePackage>20270731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Nasal Spray, reconsider the diagnosis of migraine before Sumatriptan Nasal Spray is administered to treat any subsequent attacks., 2 Sumatriptan is not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of Sumatriptan Nasal Spray have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan Nasal Spray contains sumatriptan, a selective 5-HT1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure. The empirical formula is C14H21N3O2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is readily soluble in water and in saline. Each Sumatriptan Nasal Spray contains 5 or 20 mg of sumatriptan in a 100-mcL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and purified water USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5- and 20-mg Sumatriptan Nasal Spray, respectively.</Description>
</NDC>
<NDC>
<NDCCode>67457-994-05</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>67457-0994-05</NDC11Code>
<ProductNDC>67457-994</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Regadenoson</ProprietaryName>
<NonProprietaryName>Regadenoson</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230921</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213856</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>REGADENOSON</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230921</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.</IndicationAndUsage>
<Description>Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology (12.1)]. Regadenoson is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, hemihydrate. Its structural formula is. The molecular formula for regadenoson hemihydrate is C15H18N8O5 ½H2O and its molecular weight is 399.35. Regadenoson is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL pre-filled syringe contains 0.082 mg of regadenoson hemihydrate, corresponding to 0.08 mg regadenoson on an anhydrous basis, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate, and Water for Injection, with pH between 6.3 and 7.7.</Description>
</NDC>
<NDC>
<NDCCode>71085-082-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71085-082-30) </PackageDescription>
<NDC11Code>71085-0082-30</NDC11Code>
<ProductNDC>71085-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurbiro</ProprietaryName>
<NonProprietaryName>Flurbiprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074431</ApplicationNumber>
<LabelerName>IPG Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FLURBIPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flurbiprofen tablets are indicated: 1 For relief of the signs and symptoms of rheumatoid arthritis., 2 For relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>Flurbiprofen Tablets, USP are a member of the phenylalkanoic acid derivative group of nonsteroidal anti-inflammatory drug. Flurbiprofen Tablets, USP are round, blue, film-coated debossed "NH" – "100" tablets for oral administration. Flurbiprofen, USP is a racemic mixture of (+)S- and (-)R- enantiomers. Flurbiprofen, USP is a white or slightly yellow crystalline powder. It is slightly soluble in water at pH 7.0 and readily soluble in most polar solvents. The chemical name is [1,1'-biphenyl]-4-acetic acid, 2-fluoro-α-methyl-, (±)-. It has the following structural formula. C15H13FO2 M.W. 244.26. Each tablet, for oral administration, contains 100 mg flurbiprofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and FD&C Blue #1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>72578-082-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72578-082-01) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>72578-0082-01</NDC11Code>
<ProductNDC>72578-082</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205974</ApplicationNumber>
<LabelerName>Viona Pharmaceuticals Inc</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir Ointment USP, 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white to off-white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:.</Description>
</NDC>
</NDCList>