{
"NDC": [
{
"NDCCode": "72888-228-12",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (72888-228-12) ",
"NDC11Code": "72888-0228-12",
"ProductNDC": "72888-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
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"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-228-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (72888-228-05) ",
"NDC11Code": "72888-0228-05",
"ProductNDC": "72888-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-228-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72888-228-30) ",
"NDC11Code": "72888-0228-30",
"ProductNDC": "72888-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-228-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (72888-228-60) ",
"NDC11Code": "72888-0228-60",
"ProductNDC": "72888-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-228-67",
"PackageDescription": "240 CAPSULE in 1 BOTTLE (72888-228-67) ",
"NDC11Code": "72888-0228-67",
"ProductNDC": "72888-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-198-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (72888-198-12) ",
"NDC11Code": "72888-0198-12",
"ProductNDC": "72888-198",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216736",
"LabelerName": "Advagen Pharma Ltd.,",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250325",
"SamplePackage": "N",
"IndicationAndUsage": "Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.",
"Description": "Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as dicyclomine hydrochloride tablets, USP for oral use containing 20 mg and 40 mg dicyclomine hydrochloride USP. It also contain inactive ingredients: lactose monohydrate, hypromellose, pregelatinized maize starch, FD & C Blue 1 Alu.lake, colloidal silicon dioxide and magnesium stearate. Dicyclomine hydrochloride is [bicyclohexyl]-1- carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19H 35NO 2HCl and the following structural formula:. Molecular weight: 345.95. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-199-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-199-12) ",
"NDC11Code": "72888-0199-12",
"ProductNDC": "72888-199",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolic Acid",
"NonProprietaryName": "Mycophenolic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211173",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "MYCOPHENOLATE SODIUM",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231110",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1). Use in combination with cyclosporine and corticosteroids. (1.1).",
"Description": "Mycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol and the structural formula is. Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate. The enteric coating of the tablet consists of methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate, FD&C blue #2 (180 mg) or iron oxide red (360 mg). FDA approved dissolution acceptance criteria differ from the USP dissolution acceptance criteria."
},
{
"NDCCode": "72888-200-12",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-200-12) ",
"NDC11Code": "72888-0200-12",
"ProductNDC": "72888-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolic Acid",
"NonProprietaryName": "Mycophenolic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211173",
"LabelerName": "Advagen Pharma Limited",
"SubstanceName": "MYCOPHENOLATE SODIUM",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231110",
"SamplePackage": "N",
"IndicationAndUsage": "Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1). Use in combination with cyclosporine and corticosteroids. (1.1).",
"Description": "Mycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol and the structural formula is. Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate. The enteric coating of the tablet consists of methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate, FD&C blue #2 (180 mg) or iron oxide red (360 mg). FDA approved dissolution acceptance criteria differ from the USP dissolution acceptance criteria."
},
{
"NDCCode": "72888-229-12",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (72888-229-12) ",
"NDC11Code": "72888-0229-12",
"ProductNDC": "72888-229",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "72888-230-12",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (72888-230-12) ",
"NDC11Code": "72888-0230-12",
"ProductNDC": "72888-230",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216683",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250527",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .",
"Description": "Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "21130-228-12",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "21130-0228-12",
"ProductNDC": "21130-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen And Diphenhydramine Citrate",
"NonProprietaryName": "Ibuprofen And Diphenhydramine Citrate",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216204",
"LabelerName": "Better Living Brands, LLC",
"SubstanceName": "IBUPROFEN; DIPHENHYDRAMINE CITRATE",
"StrengthNumber": "200; 38",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231115",
"SamplePackage": "N",
"IndicationAndUsage": "for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep."
},
{
"NDCCode": "41520-228-12",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (41520-228-12) > 120 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "41520-0228-12",
"ProductNDC": "41520-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"ProprietaryNameSuffix": "Enteric Safety Coated",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140430",
"EndMarketingDate": "20240329",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140430",
"EndMarketingDatePackage": "20240329",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin."
},
{
"NDCCode": "47682-228-64",
"PackageDescription": "12 PACKET in 1 BOX (47682-228-64) / 2 TABLET, FILM COATED in 1 PACKET",
"NDC11Code": "47682-0228-64",
"ProductNDC": "47682-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medique Pain Off",
"NonProprietaryName": "Acetaminophen, Aspirin, Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20081230",
"EndMarketingDate": "20230703",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20081230",
"EndMarketingDatePackage": "20230703",
"SamplePackage": "N"
},
{
"NDCCode": "50580-228-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (50580-228-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "50580-0228-24",
"ProductNDC": "50580-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benadryl Allergy Liqui-gels",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20090301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090301",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
},
{
"NDCCode": "50580-228-49",
"PackageDescription": "3 CARTON in 1 PACKAGE (50580-228-49) / 4 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "50580-0228-49",
"ProductNDC": "50580-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benadryl Allergy Liqui-gels",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20090301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Kenvue Brands LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230619",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing."
},
{
"NDCCode": "53943-228-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (53943-228-02) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "53943-0228-02",
"ProductNDC": "53943-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Multisymptom",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080909",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "DISCOUNT DRUG MART",
"SubstanceName": "ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 2; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080909",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headachenasal congestionsinus congestion and pressureminor aches and painsrunny nose and sneezing. helps clear nasal passages. helps decongest sinus openings and passages. temporarily relieves these additional symptoms of hay fever: itching of the nose or throatitchy, watery eyes."
},
{
"NDCCode": "68428-228-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-228-12) ",
"NDC11Code": "68428-0228-12",
"ProductNDC": "68428-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Sulphuratum Flavum",
"NonProprietaryName": "Arsenic Trisulfide",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101214",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ARSENIC TRISULFIDE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20101214",
"SamplePackage": "N"
},
{
"NDCCode": "68998-228-02",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (68998-228-02) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "68998-0228-02",
"ProductNDC": "68998-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Multi Symptom",
"NonProprietaryName": "Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200622",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "MARC GLASSMAN, INC.",
"SubstanceName": "CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN",
"StrengthNumber": "2; 5; 325",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200622",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headachesinus congestion and pressurenasal congestionrunny nose and sneezingminor aches and pains. temporarily relieves these additional symptoms of hay fever: itching of the nose or throatitchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages."
},
{
"NDCCode": "76420-228-12",
"PackageDescription": "120 TABLET in 1 BOTTLE (76420-228-12) ",
"NDC11Code": "76420-0228-12",
"ProductNDC": "76420-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020703",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076286",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250724",
"SamplePackage": "N",
"IndicationAndUsage": "Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1) ].",
"Description": "Tizanidine hydrochloride USP, is a central α 2-adrenergic agonist. Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S.HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets USP, are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, contain the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "79901-002-12",
"PackageDescription": "60 CONTAINER in 1 CONTAINER (79901-002-12) > 228 mL in 1 CONTAINER",
"NDC11Code": "79901-0002-12",
"ProductNDC": "79901-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Baimianqianshu Alcohol Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200812",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Zhejiang Tianbo Daily Necessities Co.Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200812",
"SamplePackage": "N",
"IndicationAndUsage": "Use to clean hands to reduce bacteria."
},
{
"NDCCode": "0220-2729-41",
"PackageDescription": "12 [hp_C] in 1 TUBE (0220-2729-41) ",
"NDC11Code": "00220-2729-41",
"ProductNDC": "0220-2729",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220816",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "12; 12; 12; 12",
"StrengthUnit": "[hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]",
"Status": "Active",
"LastUpdate": "2022-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220816",
"SamplePackage": "N",
"IndicationAndUsage": "After effects of flu or flu-like symptoms*."
},
{
"NDCCode": "0220-5085-41",
"PackageDescription": "80 PELLET in 1 TUBE (0220-5085-41) ",
"NDC11Code": "00220-5085-41",
"ProductNDC": "0220-5085",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Influenzinum",
"NonProprietaryName": "Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated),influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230918",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "12; 12; 12; 12",
"StrengthUnit": "[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230918",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves after effects of flu or flu-like symptoms *. See symptoms on front panel."
},
{
"NDCCode": "0409-4168-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4168-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4168-03",
"ProductNDC": "0409-4168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100819",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019374",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE",
"StrengthNumber": "789; 1576; 265; 206; 228; 272; 88; 789; 660; 507; 154; 448; 221; 33; 660",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10812-228-01",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10812-228-01) > 10.4 g in 1 TUBE",
"NDC11Code": "10812-0228-01",
"ProductNDC": "10812-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Skin 3 In 1 Concealer For Eyes",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf20 - Light",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130524",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "95",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-12-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "14534-228-03",
"PackageDescription": "25 kg in 1 DRUM (14534-228-03) ",
"NDC11Code": "14534-0228-03",
"ProductNDC": "14534-228",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Methyl Salicylate",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20080520",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "JQC (Huayin) Pharmaceutical Co., Ltd.",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-16",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20-MAY-08"
},
{
"NDCCode": "23155-228-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-228-01) ",
"NDC11Code": "23155-0228-01",
"ProductNDC": "23155-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074891",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130808",
"SamplePackage": "N",
"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir tablets, USP is a formulation for oral administration. Each tablet for oral administration contains 400 mg or 800 mg of acyclovir, USP. In addition each tablet contains the following inactive ingredients, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
},
{
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"PackageDescription": "500 TABLET in 1 BOTTLE (23155-228-05) ",
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"ProductNDC": "23155-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074891",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
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"LastUpdate": "2026-08-25",
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"IndicationAndUsage": "Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).",
"Description": "Acyclovir tablets, USP is a formulation for oral administration. Each tablet for oral administration contains 400 mg or 800 mg of acyclovir, USP. In addition each tablet contains the following inactive ingredients, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy."
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"ProductNDC": "24559-228",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iq Derma Regimen Hydrating Uv Shield",
"ProprietaryNameSuffix": "Spf 25",
"NonProprietaryName": "Ensulizole, Octinoxate, Oxybenzone, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "DermStore, LLC (Formerly Intelligent Beauty, LLC)",
"SubstanceName": "OCTINOXATE; OXYBENZONE; ZINC OXIDE; ENSULIZOLE",
"StrengthNumber": "7.5; 4; 3; 2",
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"Status": "Deprecated",
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{
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"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-228-01) ",
"NDC11Code": "27241-0228-01",
"ProductNDC": "27241-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215663",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
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"IndicationAndUsage": "Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD & C Blue 1, FD & C Red 3, FD & C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body & cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide."
},
{
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"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-228-30) ",
"NDC11Code": "27241-0228-30",
"ProductNDC": "27241-228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
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"LabelerName": "Ajanta Pharma USA Inc.",
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"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
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"IndicationAndUsage": "Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD & C Blue 1, FD & C Red 3, FD & C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body & cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide."
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<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
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<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome.</IndicationAndUsage>
<Description>Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available as dicyclomine hydrochloride tablets, USP for oral use containing 20 mg and 40 mg dicyclomine hydrochloride USP. It also contain inactive ingredients: lactose monohydrate, hypromellose, pregelatinized maize starch, FD & C Blue 1 Alu.lake, colloidal silicon dioxide and magnesium stearate. Dicyclomine hydrochloride is [bicyclohexyl]-1- carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19H 35NO 2HCl and the following structural formula:. Molecular weight: 345.95. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72888-199-12</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-199-12) </PackageDescription>
<NDC11Code>72888-0199-12</NDC11Code>
<ProductNDC>72888-199</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolic Acid</ProprietaryName>
<NonProprietaryName>Mycophenolic Acid</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211173</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>MYCOPHENOLATE SODIUM</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1). Use in combination with cyclosporine and corticosteroids. (1.1).</IndicationAndUsage>
<Description>Mycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol and the structural formula is. Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate. The enteric coating of the tablet consists of methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate, FD&C blue #2 (180 mg) or iron oxide red (360 mg). FDA approved dissolution acceptance criteria differ from the USP dissolution acceptance criteria.</Description>
</NDC>
<NDC>
<NDCCode>72888-200-12</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-200-12) </PackageDescription>
<NDC11Code>72888-0200-12</NDC11Code>
<ProductNDC>72888-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolic Acid</ProprietaryName>
<NonProprietaryName>Mycophenolic Acid</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211173</ApplicationNumber>
<LabelerName>Advagen Pharma Limited</LabelerName>
<SubstanceName>MYCOPHENOLATE SODIUM</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. (1.1). Use in combination with cyclosporine and corticosteroids. (1.1).</IndicationAndUsage>
<Description>Mycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol and the structural formula is. Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, povidone, colloidal silicon dioxide, talc, magnesium stearate. The enteric coating of the tablet consists of methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, iron oxide yellow, sodium lauryl sulfate, FD&C blue #2 (180 mg) or iron oxide red (360 mg). FDA approved dissolution acceptance criteria differ from the USP dissolution acceptance criteria.</Description>
</NDC>
<NDC>
<NDCCode>72888-229-12</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (72888-229-12) </PackageDescription>
<NDC11Code>72888-0229-12</NDC11Code>
<ProductNDC>72888-229</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216683</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>72888-230-12</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (72888-230-12) </PackageDescription>
<NDC11Code>72888-0230-12</NDC11Code>
<ProductNDC>72888-230</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216683</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate capsules is indicated for. : 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2 Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
<Description>Topiramate, USP is a sulfamate-substituted monosaccharide. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white powder. Topiramate, USP is the most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in dichloromethane. The solubility in water is 10.1 mg/mL. Its saturated solution has a pH of 5.32. Topiramate, USP has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate, USP is designated chemically as 2,3:4,5- Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate capsules, USP contain topiramate-coated beads in a hard gelatin capsule. The inactive ingredients are hydroxypropyl methylcellulose, sugar spheres (sucrose and starch), purified water, ethyl cellulose, polyethylene glycol, talc, ammonium hydroxide, medium chain triglycerides, oleic acid, gelatin, titanium dioxide and sodium lauryl sulphate. The black printing ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>21130-228-12</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-228-12) / 40 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0228-12</NDC11Code>
<ProductNDC>21130-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen And Diphenhydramine Citrate</ProprietaryName>
<NonProprietaryName>Ibuprofen And Diphenhydramine Citrate</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216204</ApplicationNumber>
<LabelerName>Better Living Brands, LLC</LabelerName>
<SubstanceName>IBUPROFEN; DIPHENHYDRAMINE CITRATE</SubstanceName>
<StrengthNumber>200; 38</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for relief of occasional sleeplessness when associated with minor aches and pains. helps you fall asleep and stay asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-228-12</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (41520-228-12) > 120 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>41520-0228-12</NDC11Code>
<ProductNDC>41520-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<ProprietaryNameSuffix>Enteric Safety Coated</ProprietaryNameSuffix>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140430</StartMarketingDate>
<EndMarketingDate>20240329</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Care One (American Sales Company)</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140430</StartMarketingDatePackage>
<EndMarketingDatePackage>20240329</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>47682-228-64</NDCCode>
<PackageDescription>12 PACKET in 1 BOX (47682-228-64) / 2 TABLET, FILM COATED in 1 PACKET</PackageDescription>
<NDC11Code>47682-0228-64</NDC11Code>
<ProductNDC>47682-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medique Pain Off</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin, Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081230</StartMarketingDate>
<EndMarketingDate>20230703</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20081230</StartMarketingDatePackage>
<EndMarketingDatePackage>20230703</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50580-228-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (50580-228-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50580-0228-24</NDC11Code>
<ProductNDC>50580-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benadryl Allergy Liqui-gels</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50580-228-49</NDCCode>
<PackageDescription>3 CARTON in 1 PACKAGE (50580-228-49) / 4 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50580-0228-49</NDC11Code>
<ProductNDC>50580-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benadryl Allergy Liqui-gels</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitching of the nose or throat. temporarily relieves these symptoms due to the common cold: runny nosesneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53943-228-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (53943-228-02) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53943-0228-02</NDC11Code>
<ProductNDC>53943-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Multisymptom</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080909</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>DISCOUNT DRUG MART</LabelerName>
<SubstanceName>ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 2; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080909</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headachenasal congestionsinus congestion and pressureminor aches and painsrunny nose and sneezing. helps clear nasal passages. helps decongest sinus openings and passages. temporarily relieves these additional symptoms of hay fever: itching of the nose or throatitchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-228-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-228-12) </PackageDescription>
<NDC11Code>68428-0228-12</NDC11Code>
<ProductNDC>68428-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName>
<NonProprietaryName>Arsenic Trisulfide</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ARSENIC TRISULFIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68998-228-02</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (68998-228-02) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68998-0228-02</NDC11Code>
<ProductNDC>68998-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Multi Symptom</ProprietaryName>
<NonProprietaryName>Acetaminophen, Chlorpheniramine Maleate, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200622</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>MARC GLASSMAN, INC.</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>2; 5; 325</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headachesinus congestion and pressurenasal congestionrunny nose and sneezingminor aches and pains. temporarily relieves these additional symptoms of hay fever: itching of the nose or throatitchy, watery eyes. helps clear nasal passages. helps decongest sinus openings and passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-228-12</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (76420-228-12) </PackageDescription>
<NDC11Code>76420-0228-12</NDC11Code>
<ProductNDC>76420-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020703</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076286</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tizanidine tablet is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine tablets should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration ( 2.1) ].</IndicationAndUsage>
<Description>Tizanidine hydrochloride USP, is a central α 2-adrenergic agonist. Tizanidine hydrochloride USP is almost white to slightly yellow crystalline powder, which is slightly soluble in water and methanol. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole monohydrochloride. Tizanidine’s molecular formula is C 9H 8ClN 5S.HCl, its molecular weight is 290.2 and its structural formula is:. Tizanidine tablets USP, are supplied as 2 mg and 4 mg tablets for oral administration. Tizanidine tablets USP, contain the active ingredient, tizanidine hydrochloride USP (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, anhydrous lactose, microcrystalline cellulose, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>79901-002-12</NDCCode>
<PackageDescription>60 CONTAINER in 1 CONTAINER (79901-002-12) > 228 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>79901-0002-12</NDC11Code>
<ProductNDC>79901-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Baimianqianshu Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200812</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Zhejiang Tianbo Daily Necessities Co.Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200812</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use to clean hands to reduce bacteria.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-2729-41</NDCCode>
<PackageDescription>12 [hp_C] in 1 TUBE (0220-2729-41) </PackageDescription>
<NDC11Code>00220-2729-41</NDC11Code>
<ProductNDC>0220-2729</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Hemagglutinin Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220816</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]; [hp_C]/12[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>After effects of flu or flu-like symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0220-5085-41</NDCCode>
<PackageDescription>80 PELLET in 1 TUBE (0220-5085-41) </PackageDescription>
<NDC11Code>00220-5085-41</NDC11Code>
<ProductNDC>0220-5085</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Influenzinum</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 Ivr-228 (h3n2) Hemagglutinin Antigen (uv, Formaldehyde Inactivated),influenza B Virus B/michigan/01/2021 Hemagglutinin Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Hemagglutinin Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230918</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) HEMAGGLUTININ ANTIGEN (UV, FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/1; [hp_C]/1; [hp_C]/1; [hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves after effects of flu or flu-like symptoms *. See symptoms on front panel.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-4168-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4168-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4168-03</NDC11Code>
<ProductNDC>0409-4168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100819</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019374</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>789; 1576; 265; 206; 228; 272; 88; 789; 660; 507; 154; 448; 221; 33; 660</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10812-228-01</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (10812-228-01) > 10.4 g in 1 TUBE</PackageDescription>
<NDC11Code>10812-0228-01</NDC11Code>
<ProductNDC>10812-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Skin 3 In 1 Concealer For Eyes</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf20 - Light</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>95</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-12-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>14534-228-03</NDCCode>
<PackageDescription>25 kg in 1 DRUM (14534-228-03) </PackageDescription>
<NDC11Code>14534-0228-03</NDC11Code>
<ProductNDC>14534-228</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Methyl Salicylate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20080520</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>JQC (Huayin) Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-16</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-MAY-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>23155-228-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (23155-228-01) </PackageDescription>
<NDC11Code>23155-0228-01</NDC11Code>
<ProductNDC>23155-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074891</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir tablets, USP is a formulation for oral administration. Each tablet for oral administration contains 400 mg or 800 mg of acyclovir, USP. In addition each tablet contains the following inactive ingredients, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>23155-228-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (23155-228-05) </PackageDescription>
<NDC11Code>23155-0228-05</NDC11Code>
<ProductNDC>23155-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074891</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).</IndicationAndUsage>
<Description>Acyclovir tablets, USP is a formulation for oral administration. Each tablet for oral administration contains 400 mg or 800 mg of acyclovir, USP. In addition each tablet contains the following inactive ingredients, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide and sodium starch glycolate. Acyclovir, USP is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir, USP are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula. VIROLOGY. Mechanism of Antiviral Action:. Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared with VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL. Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.</Description>
</NDC>
<NDC>
<NDCCode>24559-228-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (24559-228-02) > 50 g in 1 TUBE (24559-228-01)</PackageDescription>
<NDC11Code>24559-0228-02</NDC11Code>
<ProductNDC>24559-228</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iq Derma Regimen Hydrating Uv Shield</ProprietaryName>
<ProprietaryNameSuffix>Spf 25</ProprietaryNameSuffix>
<NonProprietaryName>Ensulizole, Octinoxate, Oxybenzone, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>DermStore, LLC (Formerly Intelligent Beauty, LLC)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE; ZINC OXIDE; ENSULIZOLE</SubstanceName>
<StrengthNumber>7.5; 4; 3; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>27241-228-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-228-01) </PackageDescription>
<NDC11Code>27241-0228-01</NDC11Code>
<ProductNDC>27241-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215663</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD & C Blue 1, FD & C Red 3, FD & C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body & cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>27241-228-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-228-30) </PackageDescription>
<NDC11Code>27241-0228-30</NDC11Code>
<ProductNDC>27241-228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215663</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate extended-release capsules are indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome (LGS) in patients 6 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate, USP, is a sulfamate-substituted monosaccharide. Topiramate extended-release capsules are available as 25 mg, 50 mg, 100 mg, and 200 mg capsules for oral administration. Topiramate is a white to off-white powder. Topiramate is freely soluble in Dichloromethane. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.4. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate extended-release capsules contain the following inactive ingredients: sugar spheres, hypromellose, ethyl cellulose, ammonium hydroxide, triglyceride, oleic acid, polyethylene glycol, povidone, glyceryl dibehenate, polyvinyl alcohol, titanium dioxide, talc, lecithin, xanthan gum. The capsule shell contains: gelatin, titanium dioxide, (25 mg, 50 mg, 100 mg and 200 mg), sodium lauryl sulfate (100 mg). FD & C Blue 1, FD & C Red 3, FD & C Red 40 (25 mg, 100 mg and 200 mg), iron oxide yellow, iron oxide red (50 mg). For 25 mg, 50 mg, 100 mg (body & cap) and 200 mg (body only) strengths, imprinting black ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide. For 200 mg (cap only) strength, imprinting white ink contains: shellac, ethanol, isopropyl alcohol, n-butanol, propylene glycol, ammonia solution, potassium hydroxide and titanium dioxide.</Description>
</NDC>
</NDCList>