{
"NDC": [
{
"NDCCode": "55741-600-34",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (55741-600-34) / 8 TABLET in 1 BLISTER PACK",
"NDC11Code": "55741-0600-34",
"ProductNDC": "55741-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Doans",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Magnesium Salicylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "MAGNESIUM SALICYLATE",
"StrengthNumber": "580",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor backache pain."
},
{
"NDCCode": "55741-600-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55741-600-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "55741-0600-01",
"ProductNDC": "55741-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Doans",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Magnesium Salicylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "MAGNESIUM SALICYLATE",
"StrengthNumber": "580",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250201",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor backache pain."
},
{
"NDCCode": "55741-600-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (55741-600-30) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "55741-0600-30",
"ProductNDC": "55741-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Doans",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Magnesium Salicylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Dr. Reddy's Laboratories Inc.",
"SubstanceName": "MAGNESIUM SALICYLATE",
"StrengthNumber": "580",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260501",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor backache pain."
},
{
"NDCCode": "41163-600-34",
"PackageDescription": "237 mL in 1 BOTTLE (41163-600-34) ",
"NDC11Code": "41163-0600-34",
"ProductNDC": "41163-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Stomach Relief",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20041007",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "Supervalu Inc",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "1050",
"StrengthUnit": "mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20041007",
"SamplePackage": "N"
},
{
"NDCCode": "65753-600-34",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (65753-600-34) ",
"NDC11Code": "65753-0600-34",
"ProductNDC": "65753-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coretex Sun X 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190816",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "CoreTex Products Inc",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "2.4; 12; 4; 4.8",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190816",
"SamplePackage": "N"
},
{
"NDCCode": "73905-002-34",
"PackageDescription": "600 mL in 1 BOTTLE (73905-002-34) ",
"NDC11Code": "73905-0002-34",
"ProductNDC": "73905-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Disnfectant",
"NonProprietaryName": "75% Alcohol Disnfectant",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"EndMarketingDate": "20240423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200330",
"EndMarketingDatePackage": "20240423",
"SamplePackage": "N"
},
{
"NDCCode": "76162-600-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (76162-600-34) / 237 mL in 1 BOTTLE",
"NDC11Code": "76162-0600-34",
"ProductNDC": "76162-600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topcare Tussin Dm",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220511",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "20; 200",
"StrengthUnit": "mg/20mL; mg/20mL",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220520",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes."
},
{
"NDCCode": "0025-1381-34",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0025-1381-34) ",
"NDC11Code": "00025-1381-34",
"ProductNDC": "0025-1381",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daypro",
"NonProprietaryName": "Oxaprozin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19921029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018841",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "OXAPROZIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19921029",
"SamplePackage": "N"
},
{
"NDCCode": "0093-7490-34",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0093-7490-34) ",
"NDC11Code": "00093-7490-34",
"ProductNDC": "0093-7490",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160603",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078061",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160603",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "0093-8244-34",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (0093-8244-34) ",
"NDC11Code": "00093-8244-34",
"ProductNDC": "0093-8244",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linezolid",
"NonProprietaryName": "Linezolid",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150622",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021130",
"LabelerName": "Teva Pharmaceuticals USA Inc",
"SubstanceName": "LINEZOLID",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20150622",
"SamplePackage": "N"
},
{
"NDCCode": "0338-0499-03",
"PackageDescription": "500 mL in 1 BAG (0338-0499-03)",
"NDC11Code": "00338-0499-03",
"ProductNDC": "0338-0499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prosol",
"NonProprietaryName": "Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020849",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0338-0499-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0499-04)",
"NDC11Code": "00338-0499-04",
"ProductNDC": "0338-0499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prosol",
"NonProprietaryName": "Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020849",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0338-0499-06",
"PackageDescription": "2000 mL in 1 BAG (0338-0499-06) ",
"NDC11Code": "00338-0499-06",
"ProductNDC": "0338-0499",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prosol",
"NonProprietaryName": "Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19980826",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020849",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19980826",
"SamplePackage": "N",
"IndicationAndUsage": "PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patients.",
"Description": "PROSOL 20% (amino acids) injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. PROSOL is not for direct intravenous infusion. The formulas for the individual amino acids found in PROSOL are provided in Table 4. PROSOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0378-0835-34",
"PackageDescription": "125 mL in 1 BOTTLE, DISPENSING (0378-0835-34)",
"NDC11Code": "00378-0835-34",
"ProductNDC": "0378-0835",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20160610",
"EndMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065358",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "600; 42.9",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4902-34",
"PackageDescription": "10 CARTON in 1 CONTAINER (0409-4902-34) / 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE (0409-4902-64) ",
"NDC11Code": "00409-4902-34",
"ProductNDC": "0409-4902",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextrose",
"NonProprietaryName": "Dextrose Monohydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20051207",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "DEXTROSE MONOHYDRATE",
"StrengthNumber": "25",
"StrengthUnit": "g/50mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20051207",
"SamplePackage": "N",
"IndicationAndUsage": "Dextrose (50%) Injection is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older.",
"Description": "Dextrose, USP is chemically designated C6H12O6 H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula. Water for Injection, USP is chemically designated H2O. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. Dextrose Injection, USP (50%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection. Each milliliter (mL) of fluid contains 0.5 grams of dextrose, hydrous which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 2.53 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The Dextrose Injection (50%) vial contains no more than 600 mcg/L of aluminum. The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied as single-dose containers. Dextrose is derived from corn."
},
{
"NDCCode": "0456-0400-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) ",
"NDC11Code": "00456-0400-10",
"ProductNDC": "0456-0400",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "400",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
},
{
"NDCCode": "0456-0600-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) ",
"NDC11Code": "00456-0600-10",
"ProductNDC": "0456-0600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teflaro",
"NonProprietaryName": "Ceftaroline Fosamil",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101029",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200327",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "CEFTAROLINE FOSAMIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101029",
"SamplePackage": "N",
"IndicationAndUsage": "Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).",
"Description": "TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5."
},
{
"NDCCode": "0536-1161-34",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "00536-1161-34",
"ProductNDC": "0536-1161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucus Relief Dm Extended Release Caplets",
"NonProprietaryName": "Guaifenesin, Dextromethorphan Hbr",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20181213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209692",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "600; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181213",
"EndMarketingDatePackage": "20270228",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
},
{
"NDCCode": "0536-1446-34",
"PackageDescription": "1 BOTTLE in 1 CARTON (0536-1446-34) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "00536-1446-34",
"ProductNDC": "0536-1446",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rugby Mucus Relief Dm Er",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207602",
"LabelerName": "Rugby Laboratories",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "30; 600",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250402",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep."
},
{
"NDCCode": "0924-5202-01",
"PackageDescription": ".34 g in 1 POUCH (0924-5202-01) ",
"NDC11Code": "00924-5202-01",
"ProductNDC": "0924-5202",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sting Relief Pad",
"NonProprietaryName": "Benzocaine, Isopropyl Alcohol",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180509",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Acme United Corporation",
"SubstanceName": "BENZOCAINE; ISOPROPYL ALCOHOL",
"StrengthNumber": "60; 600",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180509",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites. First aid to help prevent infection in minor cuts, scrapes and burns."
},
{
"NDCCode": "16571-600-96",
"PackageDescription": "12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE",
"NDC11Code": "16571-0600-96",
"ProductNDC": "16571-600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cromolyn Sodium",
"NonProprietaryName": "Cromolyn Sodium",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20111205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202583",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "CROMOLYN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2022-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111205",
"SamplePackage": "N",
"IndicationAndUsage": "Cromolyn Sodium Oral Solution, Concentrate is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.",
"Description": "Each 5 mL ampule of Cromolyn Sodium Oral Solution, Concentrate contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution, Concentrate is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate] The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is. Pharmacologic Category: Mast cell stabilizer. Therapeutic Category: Antiallergic."
},
{
"NDCCode": "24658-708-34",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (24658-708-34) ",
"NDC11Code": "24658-0708-34",
"ProductNDC": "24658-708",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20200430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207531",
"LabelerName": "PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200430",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin monohydrate, USP, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one monohydrate. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12∙H2O, and its molecular weight is 767.00. Azithromycin has the following structural formula. Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 600 mg, or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: colloidal silicon dioxide, FD & C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, natural and artificial banana flavor, natural and artificial cherry flavor and xanthan gum. After constitution, each 5 mL of suspension contains 200 mg of azithromycin, USP. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color."
},
{
"NDCCode": "33261-146-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-146-30)",
"NDC11Code": "33261-0146-30",
"ProductNDC": "33261-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075034",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. The chemical name is 5-(2,5-Dimethylphenoxy)-2,2-dimethyl pentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.34; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "33261-146-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-146-60)",
"NDC11Code": "33261-0146-60",
"ProductNDC": "33261-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075034",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. The chemical name is 5-(2,5-Dimethylphenoxy)-2,2-dimethyl pentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.34; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "33261-146-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-146-90)",
"NDC11Code": "33261-0146-90",
"ProductNDC": "33261-146",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075034",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.",
"Description": "Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. The chemical name is 5-(2,5-Dimethylphenoxy)-2,2-dimethyl pentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.34; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
},
{
"NDCCode": "33342-417-34",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-417-34) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0417-34",
"ProductNDC": "33342-417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212987",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240908",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, colorless crystals or a white crystalline powder. It is odorless with a salty taste, freely soluble in water, practically insoluble in ethanol. Inactive Ingredients: Hydrogenated vegetable oil, colloidal-silicon-dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test."
},
{
"NDCCode": "33342-418-34",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-418-34) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0418-34",
"ProductNDC": "33342-418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20240908",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212987",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240908",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, colorless crystals or a white crystalline powder. It is odorless with a salty taste, freely soluble in water, practically insoluble in ethanol. Inactive Ingredients: Hydrogenated vegetable oil, colloidal-silicon-dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test."
},
{
"NDCCode": "42806-151-34",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (42806-151-34) ",
"NDC11Code": "42806-0151-34",
"ProductNDC": "42806-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180410",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207531",
"LabelerName": "Epic Pharma, LLC",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Macrolide Antimicrobial [EPC], Macrolides [CS]",
"Status": "Active",
"LastUpdate": "2026-02-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180410",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].",
"Description": "Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one monohydrate. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12∙H2O, and its molecular weight is 767.00. Azithromycin has the following structural formula. Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: colloidal silicon dioxide, FD & C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, natural and artificial banana flavor, natural and artificial cherry flavor and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color."
},
{
"NDCCode": "50090-1016-0",
"PackageDescription": "10 SYRINGE in 1 PACKAGE (50090-1016-0) / 2 mL in 1 SYRINGE",
"NDC11Code": "50090-1016-00",
"ProductNDC": "50090-1016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bicillin L-a",
"NonProprietaryName": "Penicillin G Benzathine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19520627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050141",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PENICILLIN G BENZATHINE",
"StrengthNumber": "1200000",
"StrengthUnit": "[iU]/2mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150706",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine. Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. Venereal infections—Syphilis, yaws, bejel, and pinta. Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis. Rheumatic fever and/or chorea—Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.",
"Description": "Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows. Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.65% sodium citrate, 0.59% povidone, 0.54% carboxymethylcellulose sodium, 0.53% lecithin, 0.12% methylparaben, and 0.013% propylparaben. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G). Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000 (actual volume of 1.17 mL contains 620,100), 1,200,000 (actual volume of 2.34 mL contains 1,240,200), and 2,400,000 (actual volume of 4.67 mL contains 2,475,100) units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use."
},
{
"NDCCode": "50090-1016-1",
"PackageDescription": "1 SYRINGE in 1 PACKAGE (50090-1016-1) / 2 mL in 1 SYRINGE",
"NDC11Code": "50090-1016-01",
"ProductNDC": "50090-1016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bicillin L-a",
"NonProprietaryName": "Penicillin G Benzathine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19520627",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050141",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PENICILLIN G BENZATHINE",
"StrengthNumber": "1200000",
"StrengthUnit": "[iU]/2mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2023-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150706",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine. Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. Venereal infections—Syphilis, yaws, bejel, and pinta. Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis. Rheumatic fever and/or chorea—Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.",
"Description": "Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows. Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.65% sodium citrate, 0.59% povidone, 0.54% carboxymethylcellulose sodium, 0.53% lecithin, 0.12% methylparaben, and 0.013% propylparaben. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G). Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000 (actual volume of 1.17 mL contains 620,100), 1,200,000 (actual volume of 2.34 mL contains 1,240,200), and 2,400,000 (actual volume of 4.67 mL contains 2,475,100) units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use."
}
]
}
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<IndicationAndUsage>for the temporary relief of minor backache pain.</IndicationAndUsage>
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<PackageDescription>1 BOTTLE in 1 CARTON (55741-600-01) / 100 TABLET in 1 BOTTLE</PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>for the temporary relief of minor backache pain.</IndicationAndUsage>
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<NDC>
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<ProductNDC>41163-600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Stomach Relief</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041007</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>Supervalu Inc</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>1050</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>65753-600-34</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, PLASTIC (65753-600-34) </PackageDescription>
<NDC11Code>65753-0600-34</NDC11Code>
<ProductNDC>65753-600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coretex Sun X 50</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>CoreTex Products Inc</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>2.4; 12; 4; 4.8</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>73905-002-34</NDCCode>
<PackageDescription>600 mL in 1 BOTTLE (73905-002-34) </PackageDescription>
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<ProprietaryName>75% Alcohol Disnfectant</ProprietaryName>
<NonProprietaryName>75% Alcohol Disnfectant</NonProprietaryName>
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<EndMarketingDate>20240423</EndMarketingDate>
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<LabelerName>ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<EndMarketingDatePackage>20240423</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topcare Tussin Dm</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20220511</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 200</StrengthNumber>
<StrengthUnit>mg/20mL; mg/20mL</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0025-1381-34</NDCCode>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19921029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018841</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>OXAPROZIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19921029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-7490-34</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (0093-7490-34) </PackageDescription>
<NDC11Code>00093-7490-34</NDC11Code>
<ProductNDC>0093-7490</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160603</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078061</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160603</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0093-8244-34</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (0093-8244-34) </PackageDescription>
<NDC11Code>00093-8244-34</NDC11Code>
<ProductNDC>0093-8244</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linezolid</ProprietaryName>
<NonProprietaryName>Linezolid</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150622</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021130</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA Inc</LabelerName>
<SubstanceName>LINEZOLID</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Oxazolidinone Antibacterial [EPC],Oxazolidinones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0338-0499-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0499-03)</PackageDescription>
<NDC11Code>00338-0499-03</NDC11Code>
<ProductNDC>0338-0499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prosol</ProprietaryName>
<NonProprietaryName>Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020849</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0338-0499-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0499-04)</PackageDescription>
<NDC11Code>00338-0499-04</NDC11Code>
<ProductNDC>0338-0499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prosol</ProprietaryName>
<NonProprietaryName>Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020849</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0338-0499-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-0499-06) </PackageDescription>
<NDC11Code>00338-0499-06</NDC11Code>
<ProductNDC>0338-0499</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prosol</ProprietaryName>
<NonProprietaryName>Valine, Lysine, Histidine, Isoleucine, Leucine, Phenylalanine, Threonine, Methionine, Tryptophan, Alanine, Glycine, Arginine, Proline, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19980826</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020849</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>VALINE; LYSINE ACETATE; HISTIDINE; ISOLEUCINE; LEUCINE; PHENYLALANINE; THREONINE; METHIONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>1.44; 1.35; 1.18; 1.08; 1.08; 1; 980; 760; 320; 2.76; 2.06; 1.96; 1.34; 1.02; 1.02; 600; 50</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROSOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PROSOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>PROSOL 20% (amino acids) injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. PROSOL is not for direct intravenous infusion. The formulas for the individual amino acids found in PROSOL are provided in Table 4. PROSOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0378-0835-34</NDCCode>
<PackageDescription>125 mL in 1 BOTTLE, DISPENSING (0378-0835-34)</PackageDescription>
<NDC11Code>00378-0835-34</NDC11Code>
<ProductNDC>0378-0835</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160610</StartMarketingDate>
<EndMarketingDate>20180228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065358</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>600; 42.9</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [Chemical/Ingredient],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4902-34</NDCCode>
<PackageDescription>10 CARTON in 1 CONTAINER (0409-4902-34) / 1 SYRINGE in 1 CARTON / 50 mL in 1 SYRINGE (0409-4902-64) </PackageDescription>
<NDC11Code>00409-4902-34</NDC11Code>
<ProductNDC>0409-4902</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextrose</ProprietaryName>
<NonProprietaryName>Dextrose Monohydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20051207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextrose (50%) Injection is indicated for the treatment of insulin-induced hypoglycemia (e.g., hyperinsulinemia, insulin shock) in adults and pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>Dextrose, USP is chemically designated C6H12O6 H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula. Water for Injection, USP is chemically designated H2O. The molecular weight of dextrose (D-glucose) monohydrate is 198.17. Dextrose Injection, USP (50%) is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection. Each milliliter (mL) of fluid contains 0.5 grams of dextrose, hydrous which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 2.53 mOsmol/mL (calculation) and the pH range is 3.2 to 6.5. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The Dextrose Injection (50%) vial contains no more than 600 mcg/L of aluminum. The solution contains no bacteriostatic, antimicrobial agent or added buffer (except for pH adjustment) and is supplied as single-dose containers. Dextrose is derived from corn.</Description>
</NDC>
<NDC>
<NDCCode>0456-0400-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) </PackageDescription>
<NDC11Code>00456-0400-10</NDC11Code>
<ProductNDC>0456-0400</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teflaro</ProprietaryName>
<NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200327</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0456-0600-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) </PackageDescription>
<NDC11Code>00456-0600-10</NDC11Code>
<ProductNDC>0456-0600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teflaro</ProprietaryName>
<NonProprietaryName>Ceftaroline Fosamil</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101029</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200327</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>CEFTAROLINE FOSAMIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: 1 Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) (1.1), 2 Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older (1.2).</IndicationAndUsage>
<Description>TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O. Figure 1: Chemical structure of ceftaroline fosamil. Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate). The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)]. The pH of the constituted solution is pH 4.8 to 6.5.</Description>
</NDC>
<NDC>
<NDCCode>0536-1161-34</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (0536-1161-34) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00536-1161-34</NDC11Code>
<ProductNDC>0536-1161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucus Relief Dm Extended Release Caplets</ProprietaryName>
<NonProprietaryName>Guaifenesin, Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209692</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>600; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181213</StartMarketingDatePackage>
<EndMarketingDatePackage>20270228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relievescough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0536-1446-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0536-1446-34) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>00536-1446-34</NDC11Code>
<ProductNDC>0536-1446</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rugby Mucus Relief Dm Er</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207602</ApplicationNumber>
<LabelerName>Rugby Laboratories</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>30; 600</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. temporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0924-5202-01</NDCCode>
<PackageDescription>.34 g in 1 POUCH (0924-5202-01) </PackageDescription>
<NDC11Code>00924-5202-01</NDC11Code>
<ProductNDC>0924-5202</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sting Relief Pad</ProprietaryName>
<NonProprietaryName>Benzocaine, Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180509</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Acme United Corporation</LabelerName>
<SubstanceName>BENZOCAINE; ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>60; 600</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites. First aid to help prevent infection in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-600-96</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (16571-600-96) > 8 AMPULE in 1 POUCH > 5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>16571-0600-96</NDC11Code>
<ProductNDC>16571-600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cromolyn Sodium</ProprietaryName>
<NonProprietaryName>Cromolyn Sodium</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202583</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>CROMOLYN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cromolyn Sodium Oral Solution, Concentrate is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.</IndicationAndUsage>
<Description>Each 5 mL ampule of Cromolyn Sodium Oral Solution, Concentrate contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution, Concentrate is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate] The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is. Pharmacologic Category: Mast cell stabilizer. Therapeutic Category: Antiallergic.</Description>
</NDC>
<NDC>
<NDCCode>24658-708-34</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (24658-708-34) </PackageDescription>
<NDC11Code>24658-0708-34</NDC11Code>
<ProductNDC>24658-708</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207531</ApplicationNumber>
<LabelerName>PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin monohydrate, USP, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one monohydrate. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12∙H2O, and its molecular weight is 767.00. Azithromycin has the following structural formula. Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 600 mg, or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: colloidal silicon dioxide, FD & C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, natural and artificial banana flavor, natural and artificial cherry flavor and xanthan gum. After constitution, each 5 mL of suspension contains 200 mg of azithromycin, USP. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.</Description>
</NDC>
<NDC>
<NDCCode>33261-146-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-146-30)</PackageDescription>
<NDC11Code>33261-0146-30</NDC11Code>
<ProductNDC>33261-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075034</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. The chemical name is 5-(2,5-Dimethylphenoxy)-2,2-dimethyl pentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.34; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>33261-146-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-146-60)</PackageDescription>
<NDC11Code>33261-0146-60</NDC11Code>
<ProductNDC>33261-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075034</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. The chemical name is 5-(2,5-Dimethylphenoxy)-2,2-dimethyl pentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.34; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>33261-146-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-146-90)</PackageDescription>
<NDC11Code>33261-0146-90</NDC11Code>
<ProductNDC>33261-146</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075034</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Gemfibrozil tablets, USP are indicated as adjunctive therapy to diet for: 1 Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia., 2 Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY.</IndicationAndUsage>
<Description>Gemfibrozil is a lipid regulating agent. Gemfibrozil Tablets, USP for oral administration, contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide. The chemical name is 5-(2,5-Dimethylphenoxy)-2,2-dimethyl pentanoic acid, with the following structural formula. The molecular formula is C15H22O3 and the molecular weight is 250.34; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58°- 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
</NDC>
<NDC>
<NDCCode>33342-417-34</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-417-34) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0417-34</NDC11Code>
<ProductNDC>33342-417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212987</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, colorless crystals or a white crystalline powder. It is odorless with a salty taste, freely soluble in water, practically insoluble in ethanol. Inactive Ingredients: Hydrogenated vegetable oil, colloidal-silicon-dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>33342-418-34</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-418-34) / 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0418-34</NDC11Code>
<ProductNDC>33342-418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240908</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212987</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, colorless crystals or a white crystalline powder. It is odorless with a salty taste, freely soluble in water, practically insoluble in ethanol. Inactive Ingredients: Hydrogenated vegetable oil, colloidal-silicon-dioxide, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP. FDA approved acceptance criteria for assay differs from USP test.</Description>
</NDC>
<NDC>
<NDCCode>42806-151-34</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (42806-151-34) </PackageDescription>
<NDC11Code>42806-0151-34</NDC11Code>
<ProductNDC>42806-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180410</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207531</ApplicationNumber>
<LabelerName>Epic Pharma, LLC</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC], Macrolides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180410</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>Azithromycin for oral suspension USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one monohydrate. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12∙H2O, and its molecular weight is 767.00. Azithromycin has the following structural formula. Azithromycin, USP, as the monohydrate, is a white to off-white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin for Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: colloidal silicon dioxide, FD & C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, sodium phosphate tribasic anhydrous, sucrose, natural and artificial banana flavor, natural and artificial cherry flavor and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP. The dry powder before constitution is off-white to pinkish in color. The suspension after constitution is pink to red in color.</Description>
</NDC>
<NDC>
<NDCCode>50090-1016-0</NDCCode>
<PackageDescription>10 SYRINGE in 1 PACKAGE (50090-1016-0) / 2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50090-1016-00</NDC11Code>
<ProductNDC>50090-1016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bicillin L-a</ProprietaryName>
<NonProprietaryName>Penicillin G Benzathine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19520627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050141</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PENICILLIN G BENZATHINE</SubstanceName>
<StrengthNumber>1200000</StrengthNumber>
<StrengthUnit>[iU]/2mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine. Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. Venereal infections—Syphilis, yaws, bejel, and pinta. Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis. Rheumatic fever and/or chorea—Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.</IndicationAndUsage>
<Description>Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows. Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.65% sodium citrate, 0.59% povidone, 0.54% carboxymethylcellulose sodium, 0.53% lecithin, 0.12% methylparaben, and 0.013% propylparaben. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G). Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000 (actual volume of 1.17 mL contains 620,100), 1,200,000 (actual volume of 2.34 mL contains 1,240,200), and 2,400,000 (actual volume of 4.67 mL contains 2,475,100) units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.</Description>
</NDC>
<NDC>
<NDCCode>50090-1016-1</NDCCode>
<PackageDescription>1 SYRINGE in 1 PACKAGE (50090-1016-1) / 2 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50090-1016-01</NDC11Code>
<ProductNDC>50090-1016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bicillin L-a</ProprietaryName>
<NonProprietaryName>Penicillin G Benzathine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19520627</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050141</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PENICILLIN G BENZATHINE</SubstanceName>
<StrengthNumber>1200000</StrengthNumber>
<StrengthUnit>[iU]/2mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine. Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. Venereal infections—Syphilis, yaws, bejel, and pinta. Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis. Rheumatic fever and/or chorea—Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.</IndicationAndUsage>
<Description>Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules of penicillin G. It is chemically designated as (2S, 5R, 6R)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with N,N' -dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows. Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.65% sodium citrate, 0.59% povidone, 0.54% carboxymethylcellulose sodium, 0.53% lecithin, 0.12% methylparaben, and 0.013% propylparaben. Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000 units of penicillin G (approximately 2.59 mg of sodium per 600,000 units of penicillin G). Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000 (actual volume of 1.17 mL contains 620,100), 1,200,000 (actual volume of 2.34 mL contains 1,240,200), and 2,400,000 (actual volume of 4.67 mL contains 2,475,100) units respectively of penicillin G as the benzathine salt. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use.</Description>
</NDC>
</NDCList>