{
"NDC": [
{
"NDCCode": "25021-190-11",
"PackageDescription": "10 VIAL in 1 CARTON (25021-190-11) / 5 mL in 1 VIAL",
"NDC11Code": "25021-0190-11",
"ProductNDC": "25021-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micafungin",
"NonProprietaryName": "Micafungin Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213363",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "MICAFUNGIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": "Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].",
"Description": "Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane."
},
{
"NDCCode": "25021-190-10",
"PackageDescription": "1 VIAL in 1 CARTON (25021-190-10) / 5 mL in 1 VIAL",
"NDC11Code": "25021-0190-10",
"ProductNDC": "25021-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micafungin",
"NonProprietaryName": "Micafungin Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213363",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "MICAFUNGIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210615",
"SamplePackage": "N",
"IndicationAndUsage": "Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].",
"Description": "Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane."
},
{
"NDCCode": "25021-190-12",
"PackageDescription": "20 VIAL in 1 CARTON (25021-190-12) / 5 mL in 1 VIAL",
"NDC11Code": "25021-0190-12",
"ProductNDC": "25021-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micafungin",
"NonProprietaryName": "Micafungin Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213363",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "MICAFUNGIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251101",
"SamplePackage": "N",
"IndicationAndUsage": "Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].",
"Description": "Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane."
},
{
"NDCCode": "25021-185-11",
"PackageDescription": "1 VIAL in 1 CARTON (25021-185-11) > 10 mL in 1 VIAL",
"NDC11Code": "25021-0185-11",
"ProductNDC": "25021-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ganciclovir",
"NonProprietaryName": "Ganciclovir Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207645",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "GANCICLOVIR SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191215",
"EndMarketingDatePackage": "20230930",
"SamplePackage": "N",
"IndicationAndUsage": "Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: : 1 treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (1.1) , 2 prevention of CMV disease in adult transplant recipients at risk for CMV disease. (1.2) .",
"Description": "Ganciclovir Injection contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Chemically, ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine and ganciclovir sodium is 9-[[2- hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The chemical structures of ganciclovir sodium and ganciclovir are:. Ganciclovir is a white to off-white crystalline powder. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022. The pKas for ganciclovir are 2.2 and 9.4. Ganciclovir Injection (ganciclovir), formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile solution. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C. Each vial contains 543 mg ganciclovir sodium equivalent to 500 mg ganciclovir. Inactive ingredients may include hydrochloric acid (QS) and sodium hydroxide (QS) added to adjust the pH. All doses in this package insert are specified in terms of ganciclovir."
},
{
"NDCCode": "25021-191-11",
"PackageDescription": "10 VIAL in 1 CARTON (25021-191-11) / 5 mL in 1 VIAL",
"NDC11Code": "25021-0191-11",
"ProductNDC": "25021-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Micafungin",
"NonProprietaryName": "Micafungin Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213363",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "MICAFUNGIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Echinocandin Antifungal [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220915",
"SamplePackage": "N",
"IndicationAndUsage": "Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].",
"Description": "Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane."
},
{
"NDCCode": "25021-201-11",
"PackageDescription": "10 VIAL in 1 CARTON (25021-201-11) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0201-11",
"ProductNDC": "25021-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mesna",
"NonProprietaryName": "Mesna",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090913",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "MESNA",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cytoprotective Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101201",
"SamplePackage": "N",
"IndicationAndUsage": "Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.",
"Description": "Mesna is a sterile, nonpyrogenic, aqueous detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows:. Mesna Injection is a sterile, nonpyrogenic, aqueous solution of colorless to light pink appearance in clear glass multidose vials for intravenous administration. Mesna Injection contains 100 mg per mL mesna, 0.25 mg per mL edetate disodium, sodium hydroxide for pH adjustment and qs with Water for Injection. Mesna Injection multidose vials also contain 10.4 mg per mL of benzyl alcohol as a preservative. The solution has a pH range of 6.5 to 7.4."
},
{
"NDCCode": "25021-673-77",
"PackageDescription": "10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE",
"NDC11Code": "25021-0673-77",
"ProductNDC": "25021-673",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glydo",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201094",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140915",
"SamplePackage": "N",
"IndicationAndUsage": "GLYDO (lidocaine HCl jelly) 2% is an amide local anesthetic indicated: : 1 for prevention and control of pain in procedures involving the male and female urethra , 2 for topical treatment of painful urethritis , 3 as an anesthetic lubricant for oral and nasal endotracheal intubation .",
"Description": "GLYDO (lidocaine HCl jelly, USP) 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). GLYDO (lidocaine HCl jelly, USP) 2% contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride, the molecular weight is 270.8. The molecular formula is C14H23ClN2O, and has the following structural formula:. GLYDO (lidocaine HCl jelly, USP) 2% also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of GLYDO (lidocaine HCl jelly, USP) 2% 6 mL or 11 mL syringes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains hypromellose, and sodium hydroxide to adjust pH to 6.0 to 7.0."
},
{
"NDCCode": "25021-751-11",
"PackageDescription": "25 VIAL in 1 CARTON (25021-751-11) / 10 mL in 1 VIAL",
"NDC11Code": "25021-0751-11",
"ProductNDC": "25021-751",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204400",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220715",
"SamplePackage": "N",
"IndicationAndUsage": "Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2) .",
"Description": "The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH."
},
{
"NDCCode": "31645-190-02",
"PackageDescription": "1 PACKAGE in 1 CARTON (31645-190-02) > 11 g in 1 PACKAGE (31645-190-01) ",
"NDC11Code": "31645-0190-02",
"ProductNDC": "31645-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Super Bb Instaready Filter Trio Bb Powder",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"EndMarketingDate": "20191231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Physicians Formula, Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "12",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160101",
"EndMarketingDatePackage": "20191231",
"SamplePackage": "N"
},
{
"NDCCode": "47593-190-11",
"PackageDescription": "3780 mL in 1 BOTTLE (47593-190-11)",
"NDC11Code": "47593-0190-11",
"ProductNDC": "47593-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-scrub",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19870112",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Ecolab Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "6.12",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "50268-190-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-190-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-190-11) ",
"NDC11Code": "50268-0190-15",
"ProductNDC": "50268-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "AvPAK",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140610",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-( 5H –dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "52272-001-11",
"PackageDescription": "190 L in 1 DEWAR (52272-001-11) ",
"NDC11Code": "52272-0001-11",
"ProductNDC": "52272-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19830827",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205849",
"LabelerName": "Albright Welding Supply Co., Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Deprecated",
"LastUpdate": "2022-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19830827",
"SamplePackage": "N"
},
{
"NDCCode": "55570-190-11",
"PackageDescription": "25 kg in 1 DRUM (55570-190-11) ",
"NDC11Code": "55570-0190-11",
"ProductNDC": "55570-190",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Copper Gluconate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20080421",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "COPPER GLUCONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-07-11",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-APR-08"
},
{
"NDCCode": "59779-190-11",
"PackageDescription": "7 CONTAINER in 1 CARTON (59779-190-11) > 24 LOZENGE in 1 CONTAINER",
"NDC11Code": "59779-0190-11",
"ProductNDC": "59779-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20091001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090711",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-09",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231"
},
{
"NDCCode": "60687-190-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-190-01) / 1 TABLET in 1 BLISTER PACK (60687-190-11) ",
"NDC11Code": "60687-0190-01",
"ProductNDC": "60687-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170215",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077987",
"LabelerName": "American Health Packaging",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170215",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:, 6 Primary dysbetalipoproteinemia., 7 Hypertriglyceridemia.",
"Description": "Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake."
},
{
"NDCCode": "65133-190-12",
"PackageDescription": "6 PACKAGE in 1 PACKAGE (65133-190-12) > 12 BOTTLE in 1 PACKAGE (65133-190-11) > 532.3 mL in 1 BOTTLE (65133-190-05) ",
"NDC11Code": "65133-0190-12",
"ProductNDC": "65133-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aire-master",
"ProprietaryNameSuffix": "Foaming Ab Triclosan Free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Aire-Master of America, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/10mL",
"Status": "Deprecated",
"LastUpdate": "2022-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160101",
"SamplePackage": "N"
},
{
"NDCCode": "65162-190-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (65162-190-11) ",
"NDC11Code": "65162-0190-11",
"ProductNDC": "65162-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075927",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100218",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.",
"Description": "Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid. Naproxen, USP has the following structures. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. Each naproxen tablet, USP is available as white tablet contains 250 mg, 375 mg or 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate."
},
{
"NDCCode": "68084-190-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68084-190-01) > 10 CAPSULE in 1 BLISTER PACK (68084-190-11)",
"NDC11Code": "68084-0190-01",
"ProductNDC": "68084-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20091210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077651",
"LabelerName": "American Health Packaging",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2015-07-17"
},
{
"NDCCode": "68428-190-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-190-11) ",
"NDC11Code": "68428-0190-11",
"ProductNDC": "68428-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Socotrina",
"NonProprietaryName": "Aloe",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100429",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ALOE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100429",
"SamplePackage": "N"
},
{
"NDCCode": "70341-190-01",
"PackageDescription": "11 g in 1 CARTON (70341-190-01)",
"NDC11Code": "70341-0190-01",
"ProductNDC": "70341-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eco Soul Luminous Photoshop Pact 21 Light Beige",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "The Saem International Co., Ltd.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".68; .44; .21",
"StrengthUnit": "g/11g; g/11g; g/11g",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "71295-102-11",
"PackageDescription": "190 g in 1 TUBE (71295-102-11) ",
"NDC11Code": "71295-0102-11",
"ProductNDC": "71295-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dual-shave 2 In 1",
"ProprietaryNameSuffix": "For Her",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170306",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Lamden, Nisan",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20170306",
"SamplePackage": "N",
"IndicationAndUsage": "FOR THE TREATMENT OF ACNE AND TO PREVENT SKIN BLEMISHES WHEN SHAVING."
},
{
"NDCCode": "72288-190-11",
"PackageDescription": "7 CONTAINER in 1 CARTON (72288-190-11) / 24 LOZENGE in 1 CONTAINER (72288-190-03) ",
"NDC11Code": "72288-0190-11",
"ProductNDC": "72288-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Care Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210809",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090711",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-09-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210809",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "84720-190-11",
"PackageDescription": "7 CONTAINER in 1 CARTON (84720-190-11) / 24 LOZENGE in 1 CONTAINER (84720-190-00) ",
"NDC11Code": "84720-0190-11",
"ProductNDC": "84720-190",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quitine Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20251204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090711",
"LabelerName": "QUITINE LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251204",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "25021-008-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (25021-008-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "25021-0008-05",
"ProductNDC": "25021-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION, GEL FORMING / DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214645",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:. 25°[α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260 to 330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears."
},
{
"NDCCode": "25021-009-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (25021-009-05) / 5 mL in 1 BOTTLE",
"NDC11Code": "25021-0009-05",
"ProductNDC": "25021-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate",
"NonProprietaryName": "Timolol Maleate",
"DosageFormName": "SOLUTION, GEL FORMING / DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214645",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260115",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:. 25°[α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260 to 330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears."
},
{
"NDCCode": "25021-052-01",
"PackageDescription": "25 VIAL in 1 CARTON (25021-052-01) / 1 mL in 1 VIAL",
"NDC11Code": "25021-0052-01",
"ProductNDC": "25021-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215654",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:. 1. Endocrine Disorders: 1 Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). , 2 Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). , 3 Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. , 4 Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. , 5 Congenital adrenal hyperplasia. , 6 Nonsuppurative thyroiditis. , 7 Hypercalcemia associated with cancer. .",
"Description": "Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5. Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
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"Description": "Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5. Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
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"IndicationAndUsage": "When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:. 1. Endocrine Disorders: 1 Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). , 2 Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). , 3 Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. , 4 Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. , 5 Congenital adrenal hyperplasia. , 6 Nonsuppurative thyroiditis. , 7 Hypercalcemia associated with cancer. .",
"Description": "Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5. Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
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"IndicationAndUsage": "Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms:. LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for Injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Ceftriaxone for Injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for Injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,* Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli*. *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of Ceftriaxone for Injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone for Injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Ceftriaxone for Injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.",
"Description": "Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula:. Ceftriaxone for Injection, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
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<IndicationAndUsage>Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
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<IndicationAndUsage>Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
</NDC>
<NDC>
<NDCCode>25021-185-11</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (25021-185-11) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0185-11</NDC11Code>
<ProductNDC>25021-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ganciclovir</ProprietaryName>
<NonProprietaryName>Ganciclovir Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207645</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>GANCICLOVIR SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191215</StartMarketingDatePackage>
<EndMarketingDatePackage>20230930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the: : 1 treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (1.1) , 2 prevention of CMV disease in adult transplant recipients at risk for CMV disease. (1.2) .</IndicationAndUsage>
<Description>Ganciclovir Injection contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Chemically, ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine and ganciclovir sodium is 9-[[2- hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The chemical structures of ganciclovir sodium and ganciclovir are:. Ganciclovir is a white to off-white crystalline powder. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022. The pKas for ganciclovir are 2.2 and 9.4. Ganciclovir Injection (ganciclovir), formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile solution. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C. Each vial contains 543 mg ganciclovir sodium equivalent to 500 mg ganciclovir. Inactive ingredients may include hydrochloric acid (QS) and sodium hydroxide (QS) added to adjust the pH. All doses in this package insert are specified in terms of ganciclovir.</Description>
</NDC>
<NDC>
<NDCCode>25021-191-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-191-11) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0191-11</NDC11Code>
<ProductNDC>25021-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Micafungin</ProprietaryName>
<NonProprietaryName>Micafungin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213363</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>MICAFUNGIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Echinocandin Antifungal [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Micafungin for injection is indicated for: : 1 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.1) and Use in Specific Populations (8.4)]., 2 Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see Use in Specific Populations (8.4)]. , 3 Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older [see Clinical Studies (14.2)]., 4 Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see Clinical Studies (14.3)].</IndicationAndUsage>
<Description>Micafungin for injection, USP is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. Each single-dose vial contains 50 mg micafungin (equivalent to 50.86 mg micafungin sodium) or 100 mg micafungin (equivalent to 101.73 mg micafungin sodium), 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). Micafungin for injection, USP must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP [see Dosage and Administration (2)]. Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5 to 7. Micafungin sodium is chemically designated as:. Pneumocandin A0,1-[(4R,5R)-4,5-dihydroxy-N2-[4-[5-[4-(pentyloxy) phenyl]-3-isoxazolyl]benzoyl]-L-ornithine]-4-[(4S)-4-hydroxy-4-[4-hydroxy-3-(sulfooxy)phenyl]-L-threonine]-, monosodium salt. The chemical structure of micafungin sodium is:. The empirical/molecular formula is C56H70N9NaO23S and the formula weight is 1292.26. Micafungin sodium is a light-sensitive, hygroscopic white powder that is freely soluble in water, isotonic sodium chloride solution, N,N-dimethylformamide and dimethylsulfoxide, slightly soluble in methyl alcohol, and practically insoluble in acetonitrile, ethyl alcohol (95%), acetone, diethyl ether and n-hexane.</Description>
</NDC>
<NDC>
<NDCCode>25021-201-11</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-201-11) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0201-11</NDC11Code>
<ProductNDC>25021-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mesna</ProprietaryName>
<NonProprietaryName>Mesna</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090913</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>MESNA</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cytoprotective Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mesna Injection is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.</IndicationAndUsage>
<Description>Mesna is a sterile, nonpyrogenic, aqueous detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. The active ingredient, mesna, is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate with a molecular formula of C2H5NaO3S2 and a molecular weight of 164.18. Its structural formula is as follows:. Mesna Injection is a sterile, nonpyrogenic, aqueous solution of colorless to light pink appearance in clear glass multidose vials for intravenous administration. Mesna Injection contains 100 mg per mL mesna, 0.25 mg per mL edetate disodium, sodium hydroxide for pH adjustment and qs with Water for Injection. Mesna Injection multidose vials also contain 10.4 mg per mL of benzyl alcohol as a preservative. The solution has a pH range of 6.5 to 7.4.</Description>
</NDC>
<NDC>
<NDCCode>25021-673-77</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>25021-0673-77</NDC11Code>
<ProductNDC>25021-673</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glydo</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201094</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GLYDO (lidocaine HCl jelly) 2% is an amide local anesthetic indicated: : 1 for prevention and control of pain in procedures involving the male and female urethra , 2 for topical treatment of painful urethritis , 3 as an anesthetic lubricant for oral and nasal endotracheal intubation .</IndicationAndUsage>
<Description>GLYDO (lidocaine HCl jelly, USP) 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). GLYDO (lidocaine HCl jelly, USP) 2% contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride, the molecular weight is 270.8. The molecular formula is C14H23ClN2O, and has the following structural formula:. GLYDO (lidocaine HCl jelly, USP) 2% also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of GLYDO (lidocaine HCl jelly, USP) 2% 6 mL or 11 mL syringes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains hypromellose, and sodium hydroxide to adjust pH to 6.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>25021-751-11</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-751-11) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0751-11</NDC11Code>
<ProductNDC>25021-751</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204400</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following: : 1 Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE). (1.1) , 2 Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. (1.2) .</IndicationAndUsage>
<Description>The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S, with a molecular weight of 405.4. The structural formula is:. Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>31645-190-02</NDCCode>
<PackageDescription>1 PACKAGE in 1 CARTON (31645-190-02) > 11 g in 1 PACKAGE (31645-190-01) </PackageDescription>
<NDC11Code>31645-0190-02</NDC11Code>
<ProductNDC>31645-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Super Bb Instaready Filter Trio Bb Powder</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<EndMarketingDate>20191231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Physicians Formula, Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<EndMarketingDatePackage>20191231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>47593-190-11</NDCCode>
<PackageDescription>3780 mL in 1 BOTTLE (47593-190-11)</PackageDescription>
<NDC11Code>47593-0190-11</NDC11Code>
<ProductNDC>47593-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-scrub</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19870112</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Ecolab Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>6.12</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50268-190-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-190-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-190-11) </PackageDescription>
<NDC11Code>50268-0190-15</NDC11Code>
<ProductNDC>50268-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-( 5H –dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>52272-001-11</NDCCode>
<PackageDescription>190 L in 1 DEWAR (52272-001-11) </PackageDescription>
<NDC11Code>52272-0001-11</NDC11Code>
<ProductNDC>52272-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19830827</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205849</ApplicationNumber>
<LabelerName>Albright Welding Supply Co., Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55570-190-11</NDCCode>
<PackageDescription>25 kg in 1 DRUM (55570-190-11) </PackageDescription>
<NDC11Code>55570-0190-11</NDC11Code>
<ProductNDC>55570-190</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Copper Gluconate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20080421</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>COPPER GLUCONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-07-11</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-APR-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>59779-190-11</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (59779-190-11) > 24 LOZENGE in 1 CONTAINER</PackageDescription>
<NDC11Code>59779-0190-11</NDC11Code>
<ProductNDC>59779-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090711</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-09</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60687-190-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-190-01) / 1 TABLET in 1 BLISTER PACK (60687-190-11) </PackageDescription>
<NDC11Code>60687-0190-01</NDC11Code>
<ProductNDC>60687-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170215</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077987</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170215</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pravastatin sodium tablets are indicated: 1 To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD)., 2 To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD., 3 As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia., 4 As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial hypercholesterolemia (HeFH)., 5 As an adjunct to diet for the treatment of adults with:, 6 Primary dysbetalipoproteinemia., 7 Hypertriglyceridemia.</IndicationAndUsage>
<Description>Pravastatin Sodium Tablets, USP is a statin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Pravastatin sodium, USP is designated chemically as 1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S-[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-. Structural formula. Pravastatin sodium, USP is an odorless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (>300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether. Pravastatin Sodium Tablets, USP for oral use contain 10 mg, 20 mg, 40 mg, and 80 mg pravastatin sodium, which is equivalent to 9.48 mg, 18.97 mg, 37.94 mg and 75.88 mg of pravastatin, respectively. Inactive ingredients include: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, mannitol, meglumine, microcrystalline cellulose and starch. The 10 mg, 20 mg and 80 mg tablets also contain D&C yellow no. 10 aluminum lake and the 40 mg tablet also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>65133-190-12</NDCCode>
<PackageDescription>6 PACKAGE in 1 PACKAGE (65133-190-12) > 12 BOTTLE in 1 PACKAGE (65133-190-11) > 532.3 mL in 1 BOTTLE (65133-190-05) </PackageDescription>
<NDC11Code>65133-0190-12</NDC11Code>
<ProductNDC>65133-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aire-master</ProprietaryName>
<ProprietaryNameSuffix>Foaming Ab Triclosan Free</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Aire-Master of America, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65162-190-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (65162-190-11) </PackageDescription>
<NDC11Code>65162-0190-11</NDC11Code>
<ProductNDC>65162-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075927</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets are indicated for. the relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis, 5 tendonitis, 6 bursitis, 7 acute gout.</IndicationAndUsage>
<Description>Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP is (S)-6-methoxy- α -methyl-2 naphthaleneacetic acid. Naproxen, USP has the following structures. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. Each naproxen tablet, USP is available as white tablet contains 250 mg, 375 mg or 500 mg of naproxen, USP for oral administration. The inactive ingredients are croscarmellose sodium, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>68084-190-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68084-190-01) > 10 CAPSULE in 1 BLISTER PACK (68084-190-11)</PackageDescription>
<NDC11Code>68084-0190-01</NDC11Code>
<ProductNDC>68084-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077651</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-07-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>68428-190-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-190-11) </PackageDescription>
<NDC11Code>68428-0190-11</NDC11Code>
<ProductNDC>68428-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Socotrina</ProprietaryName>
<NonProprietaryName>Aloe</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100429</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ALOE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70341-190-01</NDCCode>
<PackageDescription>11 g in 1 CARTON (70341-190-01)</PackageDescription>
<NDC11Code>70341-0190-01</NDC11Code>
<ProductNDC>70341-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eco Soul Luminous Photoshop Pact 21 Light Beige</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>The Saem International Co., Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.68; .44; .21</StrengthNumber>
<StrengthUnit>g/11g; g/11g; g/11g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71295-102-11</NDCCode>
<PackageDescription>190 g in 1 TUBE (71295-102-11) </PackageDescription>
<NDC11Code>71295-0102-11</NDC11Code>
<ProductNDC>71295-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dual-shave 2 In 1</ProprietaryName>
<ProprietaryNameSuffix>For Her</ProprietaryNameSuffix>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170306</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Lamden, Nisan</LabelerName>
<SubstanceName>BENZOYL PEROXIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170306</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR THE TREATMENT OF ACNE AND TO PREVENT SKIN BLEMISHES WHEN SHAVING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72288-190-11</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (72288-190-11) / 24 LOZENGE in 1 CONTAINER (72288-190-03) </PackageDescription>
<NDC11Code>72288-0190-11</NDC11Code>
<ProductNDC>72288-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basic Care Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210809</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090711</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210809</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84720-190-11</NDCCode>
<PackageDescription>7 CONTAINER in 1 CARTON (84720-190-11) / 24 LOZENGE in 1 CONTAINER (84720-190-00) </PackageDescription>
<NDC11Code>84720-0190-11</NDC11Code>
<ProductNDC>84720-190</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quitine Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090711</ApplicationNumber>
<LabelerName>QUITINE LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>25021-008-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25021-008-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>25021-0008-05</NDC11Code>
<ProductNDC>25021-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214645</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:. 25°[α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260 to 330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears.</Description>
</NDC>
<NDC>
<NDCCode>25021-009-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (25021-009-05) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>25021-0009-05</NDC11Code>
<ProductNDC>25021-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate</ProprietaryName>
<NonProprietaryName>Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214645</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:. 25°[α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is:. Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water, sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol Maleate Sterile Ophthalmic Gel Forming Solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is approximately 7.0, and the osmolarity is 260 to 330 mOsm. Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming Solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: gellan gum, tromethamine, mannitol, and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, Timolol Maleate Ophthalmic Gel Forming Solution forms a gel that is subsequently removed by the flow of tears.</Description>
</NDC>
<NDC>
<NDCCode>25021-052-01</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-052-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0052-01</NDC11Code>
<ProductNDC>25021-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215654</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:. 1. Endocrine Disorders: 1 Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). , 2 Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). , 3 Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. , 4 Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. , 5 Congenital adrenal hyperplasia. , 6 Nonsuppurative thyroiditis. , 7 Hypercalcemia associated with cancer. .</IndicationAndUsage>
<Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5. Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>25021-052-05</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-052-05) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0052-05</NDC11Code>
<ProductNDC>25021-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215654</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
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<LastUpdate>2026-08-25</LastUpdate>
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<IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:. 1. Endocrine Disorders: 1 Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). , 2 Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). , 3 Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. , 4 Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. , 5 Congenital adrenal hyperplasia. , 6 Nonsuppurative thyroiditis. , 7 Hypercalcemia associated with cancer. .</IndicationAndUsage>
<Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5. Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
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<PackageDescription>25 VIAL in 1 CARTON (25021-053-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0053-01</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthNumber>10</StrengthNumber>
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<LastUpdate>2026-08-25</LastUpdate>
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<IndicationAndUsage>When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows:. 1. Endocrine Disorders: 1 Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). , 2 Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). , 3 Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. , 4 Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. , 5 Congenital adrenal hyperplasia. , 6 Nonsuppurative thyroiditis. , 7 Hypercalcemia associated with cancer. .</IndicationAndUsage>
<Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP C22H28FNa2O8P, has a molecular weight of 516.4 and chemically is 9-fluoro-11β, 17, 21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione, 21-(dihydrogen phosphate) disodium salt. It occurs as a white to practically white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.5 and 9.5. It has the following structural formula:. Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg per mL and 10 mg per mL concentrations. Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg per mL contains dexamethasone sodium phosphate, USP equivalent to 4 mg of dexamethasone phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative); water for injection, q.s. NaOH and/or citric acid monohydrate to adjust pH if necessary. pH: 7.0 to 8.5. Each mL of Dexamethasone Sodium Phosphate Injection, USP, 10 mg per mL (Preservative Free) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
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<NDC11Code>25021-0105-10</NDC11Code>
<ProductNDC>25021-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone</ProprietaryName>
<NonProprietaryName>Ceftriaxone</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065329</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-15</LastUpdate>
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<StartMarketingDatePackage>20091105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>25021-106-10</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (25021-106-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>25021-0106-10</NDC11Code>
<ProductNDC>25021-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone</ProprietaryName>
<NonProprietaryName>Ceftriaxone</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20091105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065329</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2023-11-15</LastUpdate>
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<IndicationAndUsage>Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Ceftriaxone for Injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms:. LOWER RESPIRATORY TRACT INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains) or Moraxella catarrhalis (including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for Injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Ceftriaxone for Injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for Injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,* Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus species. URINARY TRACT INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae. UNCOMPLICATED GONORRHEA (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone for Injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIA caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae. BONE AND JOINT INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter species. INTRA-ABDOMINAL INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium species (Note: most strains of Clostridium difficile are resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae. Ceftriaxone for Injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli*. *Efficacy for this organism in this organ system was studied in fewer than ten infections. SURGICAL PROPHYLAXIS: The preoperative administration of a single 1 g dose of Ceftriaxone for Injection, USP may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery bypass surgery). Although Ceftriaxone for Injection, USP has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is indicated, a single 1 g dose of Ceftriaxone for Injection, USP provides protection from most infections due to susceptible organisms throughout the course of the procedure.</IndicationAndUsage>
<Description>Ceftriaxone for Injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 72-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C18H16N8Na2O7S33.5H2O. It has a calculated molecular weight of 661.60 and the following structural formula:. Ceftriaxone for Injection, USP is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Ceftriaxone for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
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