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{
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},
{
"NDCCode": "61037-421-23",
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},
{
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{
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"LabelerName": "Bajaj Medical, LLC",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140930",
"SamplePackage": "N"
},
{
"NDCCode": "61037-413-05",
"PackageDescription": "3785 mL in 1 JUG (61037-413-05) ",
"NDC11Code": "61037-0413-05",
"ProductNDC": "61037-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dyna-hex 75",
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"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
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"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140930",
"SamplePackage": "N"
},
{
"NDCCode": "61037-413-06",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (61037-413-06) ",
"NDC11Code": "61037-0413-06",
"ProductNDC": "61037-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dyna-hex 75",
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"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20171012",
"SamplePackage": "N"
},
{
"NDCCode": "61037-413-07",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (61037-413-07) ",
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"ProductNDC": "61037-413",
"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20171012",
"SamplePackage": "N"
},
{
"NDCCode": "61037-413-10",
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"ProductNDC": "61037-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dyna-hex 75",
"NonProprietaryName": "Antiseptic Handwash",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020111",
"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "61037-413-11",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (61037-413-11)",
"NDC11Code": "61037-0413-11",
"ProductNDC": "61037-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dyna-hex 75",
"NonProprietaryName": "Antiseptic Handwash",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140930",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020111",
"LabelerName": "Bajaj Medical, LLC",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "61037-479-02",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (61037-479-02) ",
"NDC11Code": "61037-0479-02",
"ProductNDC": "61037-479",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090191",
"LabelerName": "BAJAJ MEDICAL, LLC",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240716",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose."
},
{
"NDCCode": "61037-479-04",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA090191",
"LabelerName": "BAJAJ MEDICAL, LLC",
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"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250606",
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"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose."
},
{
"NDCCode": "61037-479-06",
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"LastUpdate": "2025-10-18",
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"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose."
},
{
"NDCCode": "61037-479-12",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
"StartMarketingDate": "20230912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090191",
"LabelerName": "BAJAJ MEDICAL, LLC",
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"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250606",
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"IndicationAndUsage": "Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
"Description": "Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose."
},
{
"NDCCode": "16714-891-01",
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"NDC11Code": "16714-0891-01",
"ProductNDC": "16714-891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan And Naproxen Sodium",
"NonProprietaryName": "Sumatriptan And Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202803",
"LabelerName": "NorthStar RxLLC",
"SubstanceName": "SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM",
"StrengthNumber": "85; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181127",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.",
"Description": "Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C14H21N3O2S●C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:The molecular formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide."
},
{
"NDCCode": "21695-954-09",
"PackageDescription": "9 TABLET, FILM COATED in 1 CONTAINER (21695-954-09)",
"NDC11Code": "21695-0954-09",
"ProductNDC": "21695-954",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treximet",
"NonProprietaryName": "Sumatriptan Succinate And Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021926",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM",
"StrengthNumber": "85; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "TREXIMET is indicated for the acute treatment of migraine attacks with or without aura in adults. Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET. TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of TREXIMET have not been established for cluster headache.",
"Description": "TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure. The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each TREXIMET Tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate, FD&C Blue No. 2, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethylcellulose, talc, and titanium dioxide."
},
{
"NDCCode": "42847-850-09",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE (42847-850-09) ",
"NDC11Code": "42847-0850-09",
"ProductNDC": "42847-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Treximet",
"NonProprietaryName": "Sumatriptan Succinate And Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20080425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021926",
"LabelerName": "Currax Pharmaceuticals LLC",
"SubstanceName": "SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM",
"StrengthNumber": "85; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080425",
"SamplePackage": "N",
"IndicationAndUsage": "TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.",
"Description": "TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2S∙C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure. The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each TREXIMET 85/500 mg tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin. Each TREXIMET 10/60 mg tablet for oral administration contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, and titanium dioxide."
},
{
"NDCCode": "43353-413-53",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (43353-413-53) ",
"NDC11Code": "43353-0413-53",
"ProductNDC": "43353-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for adult patients with partial onset seizures, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "43353-413-70",
"PackageDescription": "120 CAPSULE in 1 BOTTLE, PLASTIC (43353-413-70) ",
"NDC11Code": "43353-0413-70",
"ProductNDC": "43353-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20041230",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for adult patients with partial onset seizures, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients."
},
{
"NDCCode": "43419-413-31",
"PackageDescription": "2 CONTAINER in 1 CARTON (43419-413-31) > 15 g in 1 CONTAINER",
"NDC11Code": "43419-0413-31",
"ProductNDC": "43419-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iope Air Cushion Intense Cover 23",
"NonProprietaryName": "Zinc Oxide, Octinoxate, And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180102",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.47; 1.05; .6225",
"StrengthUnit": "g/15g; g/15g; g/15g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180102",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "43419-413-34",
"PackageDescription": "1 CONTAINER in 1 POUCH (43419-413-34) > 15 g in 1 CONTAINER",
"NDC11Code": "43419-0413-34",
"ProductNDC": "43419-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iope Air Cushion Intense Cover 23",
"NonProprietaryName": "Zinc Oxide, Octinoxate, And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180102",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.47; 1.05; .6225",
"StrengthUnit": "g/15g; g/15g; g/15g",
"Status": "Deprecated",
"LastUpdate": "2018-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180105",
"SamplePackage": "N"
},
{
"NDCCode": "43598-413-11",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (43598-413-11) / 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "43598-0413-11",
"ProductNDC": "43598-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daptomycin",
"NonProprietaryName": "Daptomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208375",
"LabelerName": "Dr.Reddy's Laboratories Inc.,",
"SubstanceName": "DAPTOMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Lipopeptide Antibacterial [EPC], Lipopeptides [CS]",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"Description": "Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake or powder containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7)]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown."
},
{
"NDCCode": "43598-768-23",
"PackageDescription": "2 SYRINGE in 1 CARTON (43598-768-23) / .5 mL in 1 SYRINGE (43598-768-11) ",
"NDC11Code": "43598-0768-23",
"ProductNDC": "43598-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate",
"NonProprietaryName": "Sumatriptan Succinate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230420",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090495",
"LabelerName": "Dr. Reddy�s Laboratories Inc.,",
"SubstanceName": "SUMATRIPTAN SUCCINATE",
"StrengthNumber": "6",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230420",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: 1 Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. , 2 Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.",
"Description": "Sumatriptan injection, USP contains sumatriptan succinate, USP a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate, USP is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white or almost white powder and is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Sumatriptan injection, USP is a clear, colorless to pale yellow, free from visible particulate matter, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection, USP solution contains 8.4 mg of sumatriptan succinate, USP equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solution is approximately 4.2 to 5.3. The osmolality of the injection is between 275 and 315 mOsm/kg."
},
{
"NDCCode": "44183-850-09",
"PackageDescription": "9 TABLET in 1 BOTTLE (44183-850-09) ",
"NDC11Code": "44183-0850-09",
"ProductNDC": "44183-850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan Succinate And Naproxen Sodium",
"NonProprietaryName": "Sumatriptan Succinate And Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150514",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021926",
"LabelerName": "Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven",
"SubstanceName": "SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM",
"StrengthNumber": "85; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180215",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan and Naproxen Sodium Tablets is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.",
"Description": "Sumatriptan and Naproxen Sodium Tablets contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2S∙C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure. The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each Sumatriptan and Naproxen Sodium Tablets 85/500 mg tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin. Each Sumatriptan and Naproxen Sodium Tablets 10/60 mg tablet for oral administration contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, and titanium dioxide."
},
{
"NDCCode": "47335-410-22",
"PackageDescription": "9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22) ",
"NDC11Code": "47335-0410-22",
"ProductNDC": "47335-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sumatriptan And Naproxen Sodium",
"NonProprietaryName": "Sumatriptan And Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202803",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM",
"StrengthNumber": "85; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180720",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks., 2 Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.",
"Description": "Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C14H21N3O2S●C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:The molecular formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks., 2 Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.",
"Description": "Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C14H21N3O2S●C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:The molecular formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide."
}
]
}
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<IndicationAndUsage>surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care . healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease . skin wound and general cleanser: helps reduce bacteria on the skin .</IndicationAndUsage>
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<Status>Active</Status>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.</IndicationAndUsage>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDCCode>61037-413-05</NDCCode>
<PackageDescription>3785 mL in 1 JUG (61037-413-05) </PackageDescription>
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<StrengthUnit>mg/100mL</StrengthUnit>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>60 mL in 1 BOTTLE, PUMP (61037-413-10)</PackageDescription>
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<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
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<NDCCode>61037-413-11</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (61037-413-11)</PackageDescription>
<NDC11Code>61037-0413-11</NDC11Code>
<ProductNDC>61037-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dyna-hex 75</ProprietaryName>
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<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<ApplicationNumber>NDA020111</ApplicationNumber>
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<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61037-479-02</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (61037-479-02) </PackageDescription>
<NDC11Code>61037-0479-02</NDC11Code>
<ProductNDC>61037-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090191</ApplicationNumber>
<LabelerName>BAJAJ MEDICAL, LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>61037-479-03</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE, PLASTIC (61037-479-03) </PackageDescription>
<NDC11Code>61037-0479-03</NDC11Code>
<ProductNDC>61037-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090191</ApplicationNumber>
<LabelerName>BAJAJ MEDICAL, LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>61037-479-04</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE, PLASTIC (61037-479-04) </PackageDescription>
<NDC11Code>61037-0479-04</NDC11Code>
<ProductNDC>61037-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090191</ApplicationNumber>
<LabelerName>BAJAJ MEDICAL, LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>61037-479-06</NDCCode>
<PackageDescription>5 mL in 1 CUP, UNIT-DOSE (61037-479-06) </PackageDescription>
<NDC11Code>61037-0479-06</NDC11Code>
<ProductNDC>61037-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090191</ApplicationNumber>
<LabelerName>BAJAJ MEDICAL, LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>61037-479-12</NDCCode>
<PackageDescription>5 mL in 1 BOX, UNIT-DOSE (61037-479-12) </PackageDescription>
<NDC11Code>61037-0479-12</NDC11Code>
<ProductNDC>61037-479</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090191</ApplicationNumber>
<LabelerName>BAJAJ MEDICAL, LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial Allergic Rhinitis. Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria. Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.</IndicationAndUsage>
<Description>Cetirizine hydrochloride, USP is an orally active and selective H 1-receptor antagonist. The chemical name is (±) - [2- [4-[(4-chlorophenyl)-phenylmethyl]-1- piperazinyl] ethoxy]acetic acid, dihydrochloride. Cetirizine hydrochloride is a racemic compound with a molecular formula of C 21H 25ClN 2O 32HCl. The molecular weight is 461.82 and the chemical structure is shown below:. Cetirizine hydrochloride, USP is a white, crystalline powder and is water soluble. Cetirizine hydrochloride oral solution, USP is a colorless to slightly yellow oral solution containing cetirizine hydrochloride at a concentration of 1 mg/mL (5 mg/5 mL) for oral administration. The pH is between 4 and 5. The inactive ingredients of the oral solution are: glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>16714-891-01</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE (16714-891-01) </PackageDescription>
<NDC11Code>16714-0891-01</NDC11Code>
<ProductNDC>16714-891</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan And Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Sumatriptan And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202803</ApplicationNumber>
<LabelerName>NorthStar RxLLC</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C14H21N3O2S●C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:The molecular formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>21695-954-09</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 CONTAINER (21695-954-09)</PackageDescription>
<NDC11Code>21695-0954-09</NDC11Code>
<ProductNDC>21695-954</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treximet</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021926</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>TREXIMET is indicated for the acute treatment of migraine attacks with or without aura in adults. Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET. TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of TREXIMET have not been established for cluster headache.</IndicationAndUsage>
<Description>TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2SC4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure. The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each TREXIMET Tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate, FD&C Blue No. 2, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethylcellulose, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>42847-850-09</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE (42847-850-09) </PackageDescription>
<NDC11Code>42847-0850-09</NDC11Code>
<ProductNDC>42847-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Treximet</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021926</ApplicationNumber>
<LabelerName>Currax Pharmaceuticals LLC</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TREXIMET is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2S∙C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure. The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each TREXIMET 85/500 mg tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin. Each TREXIMET 10/60 mg tablet for oral administration contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43353-413-53</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (43353-413-53) </PackageDescription>
<NDC11Code>43353-0413-53</NDC11Code>
<ProductNDC>43353-413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for adult patients with partial onset seizures, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>43353-413-70</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE, PLASTIC (43353-413-70) </PackageDescription>
<NDC11Code>43353-0413-70</NDC11Code>
<ProductNDC>43353-413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041230</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for adult patients with partial onset seizures, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>43419-413-31</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (43419-413-31) > 15 g in 1 CONTAINER</PackageDescription>
<NDC11Code>43419-0413-31</NDC11Code>
<ProductNDC>43419-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iope Air Cushion Intense Cover 23</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Octinoxate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180102</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.47; 1.05; .6225</StrengthNumber>
<StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180102</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43419-413-34</NDCCode>
<PackageDescription>1 CONTAINER in 1 POUCH (43419-413-34) > 15 g in 1 CONTAINER</PackageDescription>
<NDC11Code>43419-0413-34</NDC11Code>
<ProductNDC>43419-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iope Air Cushion Intense Cover 23</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Octinoxate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.47; 1.05; .6225</StrengthNumber>
<StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-413-11</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (43598-413-11) / 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>43598-0413-11</NDC11Code>
<ProductNDC>43598-413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daptomycin</ProprietaryName>
<NonProprietaryName>Daptomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208375</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Inc.,</LabelerName>
<SubstanceName>DAPTOMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Lipopeptide Antibacterial [EPC], Lipopeptides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N-decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl-threo-3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε1-lactone. The chemical structure is. The empirical formula is C72H101N17O26; the molecular weight is 1620.67. Daptomycin for injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake or powder containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration (2.7)]. The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of daptomycin for injection range in color from pale yellow to light brown.</Description>
</NDC>
<NDC>
<NDCCode>43598-768-23</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (43598-768-23) / .5 mL in 1 SYRINGE (43598-768-11) </PackageDescription>
<NDC11Code>43598-0768-23</NDC11Code>
<ProductNDC>43598-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230420</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090495</ApplicationNumber>
<LabelerName>Dr. Reddy�s Laboratories Inc.,</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: 1 Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. , 2 Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.</IndicationAndUsage>
<Description>Sumatriptan injection, USP contains sumatriptan succinate, USP a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate, USP is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white or almost white powder and is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Sumatriptan injection, USP is a clear, colorless to pale yellow, free from visible particulate matter, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection, USP solution contains 8.4 mg of sumatriptan succinate, USP equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solution is approximately 4.2 to 5.3. The osmolality of the injection is between 275 and 315 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>44183-850-09</NDCCode>
<PackageDescription>9 TABLET in 1 BOTTLE (44183-850-09) </PackageDescription>
<NDC11Code>44183-0850-09</NDC11Code>
<ProductNDC>44183-850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan Succinate And Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150514</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021926</ApplicationNumber>
<LabelerName>Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan and Naproxen Sodium Tablets is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>Sumatriptan and Naproxen Sodium Tablets contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure. The empirical formula is C14H21N3O2S∙C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure. The empirical formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, freely soluble in water at neutral pH. Each Sumatriptan and Naproxen Sodium Tablets 85/500 mg tablet for oral administration contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin. Each Sumatriptan and Naproxen Sodium Tablets 10/60 mg tablet for oral administration contains 14 mg of sumatriptan succinate equivalent to 10 mg of sumatriptan and 60 mg of naproxen sodium. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-410-22</NDCCode>
<PackageDescription>9 TABLET, FILM COATED in 1 BOTTLE (47335-410-22) </PackageDescription>
<NDC11Code>47335-0410-22</NDC11Code>
<ProductNDC>47335-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan And Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Sumatriptan And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202803</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks., 2 Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C14H21N3O2S●C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:The molecular formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>47335-410-83</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (47335-410-83) </PackageDescription>
<NDC11Code>47335-0410-83</NDC11Code>
<ProductNDC>47335-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sumatriptan And Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Sumatriptan And Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202803</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>85; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use: 1 Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks., 2 Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks., 3 Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.</IndicationAndUsage>
<Description>Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C14H21N3O2S●C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure:The molecular formula is C14H13NaO3, representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide.</Description>
</NDC>
</NDCList>