{
"NDC": [
{
"NDCCode": "55700-611-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (55700-611-10) ",
"NDC11Code": "55700-0611-10",
"ProductNDC": "55700-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20281130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "55700-611-06",
"PackageDescription": "6 TABLET in 1 BOTTLE (55700-611-06) ",
"NDC11Code": "55700-0611-06",
"ProductNDC": "55700-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20281130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190111",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "55700-611-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (55700-611-14) ",
"NDC11Code": "55700-0611-14",
"ProductNDC": "55700-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20281130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "55700-611-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (55700-611-20) ",
"NDC11Code": "55700-0611-20",
"ProductNDC": "55700-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20281130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20281130",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "55700-611-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (55700-611-28) ",
"NDC11Code": "55700-0611-28",
"ProductNDC": "55700-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20281130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180504",
"EndMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "55700-611-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (55700-611-30) ",
"NDC11Code": "55700-0611-30",
"ProductNDC": "55700-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180504",
"EndMarketingDate": "20281130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181102",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "10122-611-10",
"PackageDescription": "10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "10122-0611-10",
"ProductNDC": "10122-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cleviprex",
"NonProprietaryName": "Clevipidine",
"DosageFormName": "EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20080915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022156",
"LabelerName": "Chiesi USA, Inc.",
"SubstanceName": "CLEVIDIPINE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080915",
"SamplePackage": "N",
"IndicationAndUsage": "Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.",
"Description": "Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine suitable for intravenous administration. Clevidipine is a dihydropyridine calcium channel blocker. Chemically, the active substance, clevidipine, is butyroxymethyl methyl 4-(2´,3´-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. It is a racemic mixture with a molecular weight of 456.3 g/mol. Each enantiomer has equipotent antihypertensive activity. The structure and formula are. Clevidipine is practically insoluble in water and is formulated in an oil-in-water emulsion. In addition to the active ingredient, clevidipine, Cleviprex contains soybean oil (200 mg/mL), glycerin (22.5 mg/mL), purified egg yolk phospholipids (12 mg/mL), oleic acid (0.3 mg/mL), disodium edetate (0.05 mg/mL), and sodium hydroxide to adjust pH. Cleviprex has a pH of 6.0 – 8.0 and is a ready-to-use emulsion."
},
{
"NDCCode": "10544-611-10",
"PackageDescription": "10 TABLET in 1 BOTTLE (10544-611-10)",
"NDC11Code": "10544-0611-10",
"ProductNDC": "10544-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040409",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ACETAMINOPHEN; HYDROCODONE BITARTRATE",
"StrengthNumber": "325; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-10-17"
},
{
"NDCCode": "25021-611-10",
"PackageDescription": "10 VIAL in 1 CARTON (25021-611-10) > 10 mL in 1 VIAL",
"NDC11Code": "25021-0611-10",
"ProductNDC": "25021-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neostigmine Methylsulfate",
"NonProprietaryName": "Neostigmine Methylsulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210652",
"LabelerName": "Sagent Pharmaceuticals",
"SubstanceName": "NEOSTIGMINE METHYLSULFATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220115",
"SamplePackage": "N",
"IndicationAndUsage": "Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.",
"Description": "Neostigmine methylsulfate, USP, a cholinesterase inhibitor, is (m-hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate. The structural formula is:. Neostigmine methylsulfate, USP is a white crystalline powder and is very soluble in water and soluble in alcohol. Neostigmine Methylsulfate Injection, USP is a sterile, nonpyrogenic solution intended for intravenous use. Each mL of the 0.5 mg per mL strength contains neostigmine methylsulfate, USP 0.5 mg, phenol 4.5 mg (used as preservative) and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5. Each mL of the 1 mg per mL strength contains neostigmine methylsulfate, USP 1 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5."
},
{
"NDCCode": "31722-611-31",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-611-31) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0611-31",
"ProductNDC": "31722-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "31722-611-32",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-611-32) / 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0611-32",
"ProductNDC": "31722-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "42291-611-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-10)",
"NDC11Code": "42291-0611-10",
"ProductNDC": "42291-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078596",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "42947-611-10",
"PackageDescription": ".5 mL in 1 POUCH (42947-611-10)",
"NDC11Code": "42947-0611-10",
"ProductNDC": "42947-611",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Povidone-iodine Prep Pad",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333",
"LabelerName": "Wuxi Medical Instrument Factory",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": ".1",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Directions. Clean the affected area. Apply product on the area 1-3 times daily and discard. May be covered with a sterile bandage when dry."
},
{
"NDCCode": "43547-611-10",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10) ",
"NDC11Code": "43547-0611-10",
"ProductNDC": "43547-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201781",
"LabelerName": "Solco Healthcare U.S., LLC",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230105",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1, 3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules. Active Ingredient: temazepam, USP. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, edetate disodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The capsule shells for all strengths contain FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. The imprinting ink may contain ammonium solution, butyl alcohol, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "44567-611-10",
"PackageDescription": "10 BAG in 1 CARTON (44567-611-10) / 100 mL in 1 BAG (44567-611-01) ",
"NDC11Code": "44567-0611-10",
"ProductNDC": "44567-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam In Sodium Chloride",
"NonProprietaryName": "Midazolam",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211844",
"LabelerName": "WG Critical Care, LLC.",
"SubstanceName": "MIDAZOLAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Midazolam in 0.9% Sodium Chloride Injection is indicated: 1 Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. .",
"Description": "Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in 0.9% Sodium Chloride Injection contains either 50 mg/50 mL (1 mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 9 mg/mL of sodium chloride in water for injection. Midazolam in 0.9% Sodium Chloride Injection may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH is approximately 2.5 - 3.5. Midazolam is a white to light yellow crystalline compound, insoluble in water, freely soluble in ethanol, soluble in methanol. Chemically, midazolam is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine. Midazolam has the empirical formula C18H13ClFN3, a calculated molecular weight of 325.77 and the following structural formula."
},
{
"NDCCode": "45963-611-53",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "45963-0611-53",
"ProductNDC": "45963-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxaliplatin",
"NonProprietaryName": "Oxaliplatin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078803",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "OXALIPLATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]",
"Status": "Deprecated",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150105",
"SamplePackage": "N",
"IndicationAndUsage": "Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: : 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer. .",
"Description": "Oxaliplatin for Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.29. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Powder for solution for infusion. Oxaliplatin for Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively."
},
{
"NDCCode": "47682-611-12",
"PackageDescription": "10 PACKET in 1 BOX (47682-611-12) / .9 g in 1 PACKET",
"NDC11Code": "47682-0611-12",
"ProductNDC": "47682-611",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medi-first Hydrocortisone",
"NonProprietaryName": "1 % Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200101",
"EndMarketingDate": "20241201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200101",
"EndMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of itching associated with minor skin irritations, inflammation and rashes. for external genital, feminine, and anal itching. other uses of this product should be only under the advice and supervision of a doctor."
},
{
"NDCCode": "51407-611-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (51407-611-10) ",
"NDC11Code": "51407-0611-10",
"ProductNDC": "51407-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20061207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077918",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211007",
"SamplePackage": "N",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .",
"Description": "Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow Meloxicam Tablets contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam Tablets are available as tablets for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate."
},
{
"NDCCode": "51655-611-53",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (51655-611-53) ",
"NDC11Code": "51655-0611-53",
"ProductNDC": "51655-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020064",
"LabelerName": "Northwind Pharmaceuticals, LLC",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230113",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8."
},
{
"NDCCode": "52862-611-10",
"PackageDescription": "10 PATCH in 1 PACKET (52862-611-10) / 3.2 g in 1 PATCH",
"NDC11Code": "52862-0611-10",
"ProductNDC": "52862-611",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Health Smart Antibacterial Wet Wipes For Hands And Face",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200622",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "International Wholesale Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200622",
"SamplePackage": "N",
"IndicationAndUsage": "decreases bacteria on skin."
},
{
"NDCCode": "57297-611-10",
"PackageDescription": "10 INJECTION, POWDER, FOR SOLUTION in 1 BOX (57297-611-10)",
"NDC11Code": "57297-0611-10",
"ProductNDC": "57297-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceftriaxone",
"NonProprietaryName": "Ceftriaxone",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065125",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "CEFTRIAXONE SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Before instituting treatment with ceftriaxone, 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 sodium, 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 C18H16N8Na2O7S3 3.5H2O. It has a calculated molecular weight of 661.59 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 solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone for injection USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity."
},
{
"NDCCode": "58657-611-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (58657-611-10) ",
"NDC11Code": "58657-0611-10",
"ProductNDC": "58657-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan",
"NonProprietaryName": "Losartan Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090382",
"LabelerName": "Method Pharmaceuticals, LLC",
"SubstanceName": "LOSARTAN POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20160927",
"SamplePackage": "N"
},
{
"NDCCode": "65841-611-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (65841-611-10) ",
"NDC11Code": "65841-0611-10",
"ProductNDC": "65841-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atomoxetine",
"NonProprietaryName": "Atomoxetine",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079017",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N"
},
{
"NDCCode": "67457-611-10",
"PackageDescription": "10 VIAL in 1 CARTON (67457-611-10) > 10 mL in 1 VIAL",
"NDC11Code": "67457-0611-10",
"ProductNDC": "67457-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vancomycin Hydrochloride",
"NonProprietaryName": "Vancomycin Hydrochloride",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065397",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "VANCOMYCIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Glycopeptide Antibacterial [EPC],Glycopeptides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20081231",
"SamplePackage": "N"
},
{
"NDCCode": "67877-611-33",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (67877-611-33) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "67877-0611-33",
"ProductNDC": "67877-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide."
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"PackageDescription": "10 TABLET in 1 BOTTLE (69584-611-01) ",
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"LabelerName": "DARMERICA, LLC",
"SubstanceName": "ISONIAZID",
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{
"NDCCode": "71120-611-10",
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"NDC11Code": "71120-0611-10",
"ProductNDC": "71120-611",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "Hand Sanitizer",
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<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula. Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
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<NDC>
<NDCCode>10122-611-10</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>10122-0611-10</NDC11Code>
<ProductNDC>10122-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cleviprex</ProprietaryName>
<NonProprietaryName>Clevipidine</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20080915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022156</ApplicationNumber>
<LabelerName>Chiesi USA, Inc.</LabelerName>
<SubstanceName>CLEVIDIPINE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.</IndicationAndUsage>
<Description>Cleviprex is a sterile, milky-white emulsion containing 0.5 mg/mL of clevidipine suitable for intravenous administration. Clevidipine is a dihydropyridine calcium channel blocker. Chemically, the active substance, clevidipine, is butyroxymethyl methyl 4-(2´,3´-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. It is a racemic mixture with a molecular weight of 456.3 g/mol. Each enantiomer has equipotent antihypertensive activity. The structure and formula are. Clevidipine is practically insoluble in water and is formulated in an oil-in-water emulsion. In addition to the active ingredient, clevidipine, Cleviprex contains soybean oil (200 mg/mL), glycerin (22.5 mg/mL), purified egg yolk phospholipids (12 mg/mL), oleic acid (0.3 mg/mL), disodium edetate (0.05 mg/mL), and sodium hydroxide to adjust pH. Cleviprex has a pH of 6.0 – 8.0 and is a ready-to-use emulsion.</Description>
</NDC>
<NDC>
<NDCCode>10544-611-10</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (10544-611-10)</PackageDescription>
<NDC11Code>10544-0611-10</NDC11Code>
<ProductNDC>10544-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100517</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040409</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>325; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-10-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>25021-611-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (25021-611-10) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>25021-0611-10</NDC11Code>
<ProductNDC>25021-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neostigmine Methylsulfate</ProprietaryName>
<NonProprietaryName>Neostigmine Methylsulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210652</ApplicationNumber>
<LabelerName>Sagent Pharmaceuticals</LabelerName>
<SubstanceName>NEOSTIGMINE METHYLSULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.</IndicationAndUsage>
<Description>Neostigmine methylsulfate, USP, a cholinesterase inhibitor, is (m-hydroxyphenyl) trimethylammonium methylsulfate dimethylcarbamate. The structural formula is:. Neostigmine methylsulfate, USP is a white crystalline powder and is very soluble in water and soluble in alcohol. Neostigmine Methylsulfate Injection, USP is a sterile, nonpyrogenic solution intended for intravenous use. Each mL of the 0.5 mg per mL strength contains neostigmine methylsulfate, USP 0.5 mg, phenol 4.5 mg (used as preservative) and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5. Each mL of the 1 mg per mL strength contains neostigmine methylsulfate, USP 1 mg, phenol 4.5 mg (used as preservative), and sodium acetate trihydrate 0.2 mg, in water for injection. The pH is adjusted, when necessary, with acetic acid/sodium hydroxide to achieve a value of 5.5.</Description>
</NDC>
<NDC>
<NDCCode>31722-611-31</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-611-31) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0611-31</NDC11Code>
<ProductNDC>31722-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-611-32</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-611-32) / 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0611-32</NDC11Code>
<ProductNDC>31722-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>42291-611-10</NDCCode>
<PackageDescription>1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-611-10)</PackageDescription>
<NDC11Code>42291-0611-10</NDC11Code>
<ProductNDC>42291-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078596</ApplicationNumber>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC],Biguanides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>42947-611-10</NDCCode>
<PackageDescription>.5 mL in 1 POUCH (42947-611-10)</PackageDescription>
<NDC11Code>42947-0611-10</NDC11Code>
<ProductNDC>42947-611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Povidone-iodine Prep Pad</ProprietaryName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333</ApplicationNumber>
<LabelerName>Wuxi Medical Instrument Factory</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Clean the affected area. Apply product on the area 1-3 times daily and discard. May be covered with a sterile bandage when dry.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43547-611-10</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10) </PackageDescription>
<NDC11Code>43547-0611-10</NDC11Code>
<ProductNDC>43547-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201781</ApplicationNumber>
<LabelerName>Solco Healthcare U.S., LLC</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1, 3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules. Active Ingredient: temazepam, USP. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, edetate disodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The capsule shells for all strengths contain FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. The imprinting ink may contain ammonium solution, butyl alcohol, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>44567-611-10</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (44567-611-10) / 100 mL in 1 BAG (44567-611-01) </PackageDescription>
<NDC11Code>44567-0611-10</NDC11Code>
<ProductNDC>44567-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Midazolam</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211844</ApplicationNumber>
<LabelerName>WG Critical Care, LLC.</LabelerName>
<SubstanceName>MIDAZOLAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midazolam in 0.9% Sodium Chloride Injection is indicated: 1 Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. .</IndicationAndUsage>
<Description>Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine available as a sterile, preservative-free, nonpyrogenic solution of midazolam and sodium chloride in water for injection for intravenous use. Each single-dose bag of Midazolam in 0.9% Sodium Chloride Injection contains either 50 mg/50 mL (1 mg/mL) or 100 mg/100 mL (1 mg/mL) of midazolam and 9 mg/mL of sodium chloride in water for injection. Midazolam in 0.9% Sodium Chloride Injection may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. The pH is approximately 2.5 - 3.5. Midazolam is a white to light yellow crystalline compound, insoluble in water, freely soluble in ethanol, soluble in methanol. Chemically, midazolam is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine. Midazolam has the empirical formula C18H13ClFN3, a calculated molecular weight of 325.77 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>45963-611-53</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-53) > 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>45963-0611-53</NDC11Code>
<ProductNDC>45963-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxaliplatin</ProprietaryName>
<NonProprietaryName>Oxaliplatin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078803</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>OXALIPLATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxaliplatin for Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: : 1 adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. , 2 treatment of advanced colorectal cancer. .</IndicationAndUsage>
<Description>Oxaliplatin for Injection, USP is a platinum-based drug with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N’] [oxalato(2-)-O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.29. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Powder for solution for infusion. Oxaliplatin for Injection, USP, for intravenous use is supplied in vials containing 50 mg or 100 mg of oxaliplatin, USP as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.</Description>
</NDC>
<NDC>
<NDCCode>47682-611-12</NDCCode>
<PackageDescription>10 PACKET in 1 BOX (47682-611-12) / .9 g in 1 PACKET</PackageDescription>
<NDC11Code>47682-0611-12</NDC11Code>
<ProductNDC>47682-611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medi-first Hydrocortisone</ProprietaryName>
<NonProprietaryName>1 % Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200101</StartMarketingDate>
<EndMarketingDate>20241201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of itching associated with minor skin irritations, inflammation and rashes. for external genital, feminine, and anal itching. other uses of this product should be only under the advice and supervision of a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51407-611-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (51407-611-10) </PackageDescription>
<NDC11Code>51407-0611-10</NDC11Code>
<ProductNDC>51407-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061207</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</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>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam Tablets are a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow Meloxicam Tablets contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2and it has the following structural formula:. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app= 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam Tablets are available as tablets for oral administration containing 7.5 mg or 15 mg meloxicam. The inactive ingredients in Meloxicam Tablets include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.</Description>
</NDC>
<NDC>
<NDCCode>51655-611-53</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (51655-611-53) </PackageDescription>
<NDC11Code>51655-0611-53</NDC11Code>
<ProductNDC>51655-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020064</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals, LLC</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin monohydrate/macrocrystals capsules are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES.) Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin monohydrate/macrocrystals capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The nitrofurantoin monohydrate/macrocrystals capsules brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate. The chemical name of nitrofurantoin macrocrystals is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4-imidazolidinedione. The chemical structure is the following. Molecular Weight: 238.16. The chemical name of nitrofurantoin monohydrate is 1-[[[5-nitro-2-furanyl]methylene] amino]-2,4- imidazolidinedione monohydrate. The chemical structure is the following. Molecular Weight: 256.17. Inactive Ingredients: Each capsule contains carbomer 934P, corn starch, compressible sugar, D&C Yellow No. 10, edible gray ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 8.</Description>
</NDC>
<NDC>
<NDCCode>52862-611-10</NDCCode>
<PackageDescription>10 PATCH in 1 PACKET (52862-611-10) / 3.2 g in 1 PATCH</PackageDescription>
<NDC11Code>52862-0611-10</NDC11Code>
<ProductNDC>52862-611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Health Smart Antibacterial Wet Wipes For Hands And Face</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200622</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>International Wholesale Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>decreases bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57297-611-10</NDCCode>
<PackageDescription>10 INJECTION, POWDER, FOR SOLUTION in 1 BOX (57297-611-10)</PackageDescription>
<NDC11Code>57297-0611-10</NDC11Code>
<ProductNDC>57297-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone</ProprietaryName>
<NonProprietaryName>Ceftriaxone</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065125</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Before instituting treatment with ceftriaxone, 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 sodium, 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 C18H16N8Na2O7S3 3.5H2O. It has a calculated molecular weight of 661.59 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 solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone for injection USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.</Description>
</NDC>
<NDC>
<NDCCode>58657-611-10</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (58657-611-10) </PackageDescription>
<NDC11Code>58657-0611-10</NDC11Code>
<ProductNDC>58657-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan</ProprietaryName>
<NonProprietaryName>Losartan Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090382</ApplicationNumber>
<LabelerName>Method Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65841-611-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (65841-611-10) </PackageDescription>
<NDC11Code>65841-0611-10</NDC11Code>
<ProductNDC>65841-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atomoxetine</ProprietaryName>
<NonProprietaryName>Atomoxetine</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079017</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-611-10</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-611-10) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>67457-0611-10</NDC11Code>
<ProductNDC>67457-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vancomycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Vancomycin Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065397</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>VANCOMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Glycopeptide Antibacterial [EPC],Glycopeptides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20081231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-611-33</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (67877-611-33) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0611-33</NDC11Code>
<ProductNDC>67877-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidne Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidne Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212196</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine capsules are indicated for the treatment of spasticity in adults.</IndicationAndUsage>
<Description>Tizanidine capsules contains tizanidine hydrochloride the active ingredient, which is a central alpha2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C9H8ClN5S-HCl and a molecular weight of 290.2. Its structural formula is. Tizanidine hydrochloride is almost white to slightly yellow, crystalline powder. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Tizanidine capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride USP, respectively), and the inactive ingredients sugar spheres, hypromellose and silicon dioxide. Each capsule shell contains FD and C Blue1, FD and C Red 3 (4 mg and 6 mg), gelatin and titanium dioxide. The 2 mg and 6 mg capsule is printed with white pharmaceutical ink which contains shellac, propylene glycol, potassium hydroxide and titanium dioxide; 4 mg capsule is printed with black pharmaceutical ink which contains shellac, propylene glycol, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>68180-611-10</NDCCode>
<PackageDescription>10 INJECTION, POWDER, FOR SOLUTION in 1 BOX (68180-611-10) </PackageDescription>
<NDC11Code>68180-0611-10</NDC11Code>
<ProductNDC>68180-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone</ProprietaryName>
<NonProprietaryName>Ceftriaxone</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065125</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69584-611-01</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (69584-611-01) </PackageDescription>
<NDC11Code>69584-0611-01</NDC11Code>
<ProductNDC>69584-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69584-611-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (69584-611-10) </PackageDescription>
<NDC11Code>69584-0611-10</NDC11Code>
<ProductNDC>69584-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>Oxford Pharmaceuticals, LLC</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>71052-611-10</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (71052-611-10) </PackageDescription>
<NDC11Code>71052-0611-10</NDC11Code>
<ProductNDC>71052-611</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Isoniazid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20200421</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>ISONIAZID</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>g/1000g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-08-18</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-JUL-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>71120-611-10</NDCCode>
<PackageDescription>8 mL in 1 BOTTLE, SPRAY (71120-611-10) </PackageDescription>
<NDC11Code>71120-0611-10</NDC11Code>
<ProductNDC>71120-611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Durisan</ProprietaryName>
<ProprietaryNameSuffix>Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Sanit Technologies LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/250mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-03-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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