{
"NDC": [
{
"NDCCode": "65162-980-29",
"PackageDescription": "25 TABLET in 1 BOTTLE (65162-980-29) ",
"NDC11Code": "65162-0980-29",
"ProductNDC": "65162-980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207481",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150529",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaKeratitisOptic neuritisAllergic conjunctivitisChorioretinitisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisBerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.",
"Description": "Methylprednisolone tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in ethanol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is (6α, 11β)-11, 17, 21-Trihydroxy-6-methylpregna-1, 4-diene-3, 20-dione and the molecular weight is 374.5 g/mol. The structural formula is represented below. Each methylprednisolone tablet, USP for oral administration contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous lactose, calcium stearate, lactose monohydrate and pregelatinized starch. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli."
},
{
"NDCCode": "65162-891-29",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (65162-891-29) / 120 SPRAY, METERED in 1 BOTTLE, PUMP",
"NDC11Code": "65162-0891-29",
"ProductNDC": "65162-891",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mometasone Furoate",
"NonProprietaryName": "Mometasone",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20170404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207989",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "50",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170404",
"SamplePackage": "N",
"IndicationAndUsage": "Mometasone furoate nasal spray is a corticosteroid indicated for: : 1 Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older (1.1), 2 Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older (1.2) .",
"Description": "Mometasone furoate anhydrous, USP, the active component of mometasone furoate nasal spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), and the following chemical structure. Mometasone furoate anhydrous, USP is a white to off-white powder, with an empirical formula of C27H30Cl2O6, and a molecular weight of 521.43 g/mol. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5,000. Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate, USP in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80 and sodium citrate. The pH is between 4.3 and 4.9."
},
{
"NDCCode": "65162-982-29",
"PackageDescription": "25 TABLET in 1 BOTTLE (65162-982-29) ",
"NDC11Code": "65162-0982-29",
"ProductNDC": "65162-982",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207481",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "16",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150529",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaKeratitisOptic neuritisAllergic conjunctivitisChorioretinitisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisBerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.",
"Description": "Methylprednisolone tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in ethanol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is (6α, 11β)-11, 17, 21-Trihydroxy-6-methylpregna-1, 4-diene-3, 20-dione and the molecular weight is 374.5 g/mol. The structural formula is represented below. Each methylprednisolone tablet, USP for oral administration contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous lactose, calcium stearate, lactose monohydrate and pregelatinized starch. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli."
},
{
"NDCCode": "65162-984-29",
"PackageDescription": "25 TABLET in 1 BOTTLE (65162-984-29) ",
"NDC11Code": "65162-0984-29",
"ProductNDC": "65162-984",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylprednisolone",
"NonProprietaryName": "Methylprednisolone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207481",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "METHYLPREDNISOLONE",
"StrengthNumber": "32",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150529",
"SamplePackage": "N",
"IndicationAndUsage": "Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaKeratitisOptic neuritisAllergic conjunctivitisChorioretinitisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisBerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.",
"Description": "Methylprednisolone tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in ethanol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is (6α, 11β)-11, 17, 21-Trihydroxy-6-methylpregna-1, 4-diene-3, 20-dione and the molecular weight is 374.5 g/mol. The structural formula is represented below. Each methylprednisolone tablet, USP for oral administration contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous lactose, calcium stearate, lactose monohydrate and pregelatinized starch. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli."
},
{
"NDCCode": "10738-980-23",
"PackageDescription": "384.5 mL in 1 BOTTLE (10738-980-23) ",
"NDC11Code": "10738-0980-23",
"ProductNDC": "10738-980",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triderma Psoriasis Control",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Genuine Virgin Aloe Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "3",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200115",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Relieves and helps prevent recurrence of: itching irritation redness flaking scaling due to psoriasis and seborrheic dermatitis."
},
{
"NDCCode": "10738-980-82",
"PackageDescription": "245 mL in 1 BOTTLE, PLASTIC (10738-980-82) ",
"NDC11Code": "10738-0980-82",
"ProductNDC": "10738-980",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triderma Psoriasis Control",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Genuine Virgin Aloe Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "3",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200115",
"SamplePackage": "N",
"IndicationAndUsage": "Uses Relieves and helps prevent recurrence of: itching irritation redness flaking scaling due to psoriasis and seborrheic dermatitis."
},
{
"NDCCode": "41250-980-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (41250-980-10) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "41250-0980-10",
"ProductNDC": "41250-980",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Infants",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20100611",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Meijer Distribution Inc",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "80",
"StrengthUnit": "mg/.8mL",
"Status": "Deprecated",
"LastUpdate": "2017-11-29"
},
{
"NDCCode": "47335-980-18",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (47335-980-18) ",
"NDC11Code": "47335-0980-18",
"ProductNDC": "47335-980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205031",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220319",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "47335-980-82",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (47335-980-82) ",
"NDC11Code": "47335-0980-82",
"ProductNDC": "47335-980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205031",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220319",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "47335-980-86",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (47335-980-86) ",
"NDC11Code": "47335-0980-86",
"ProductNDC": "47335-980",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220319",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205031",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220319",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol."
},
{
"NDCCode": "58411-980-60",
"PackageDescription": "1 TUBE in 1 BOX (58411-980-60) / 21 mL in 1 TUBE",
"NDC11Code": "58411-0980-60",
"ProductNDC": "58411-980",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cle De Peau Beaute Radiant Foundation N M",
"ProprietaryNameSuffix": "O70",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Shiseido Americas Corporation",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.06; .29",
"StrengthUnit": "g/21mL; g/21mL",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241202",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "70700-112-21",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (70700-112-21) / 88 g in 1 BOTTLE, PUMP",
"NDC11Code": "70700-0112-21",
"ProductNDC": "70700-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL, METERED",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210835",
"LabelerName": "Xiromed, LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "20.25",
"StrengthUnit": "mg/1.25g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200508",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.",
"Description": "Testosterone gel, 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. Testosterone gel, 1.62% is available in a metered-dose pump. The active pharmacologic ingredient in testosterone gel, 1.62% is testosterone. Testosterone USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. The inactive ingredients in testosterone gel, 1.62% are: carbopol 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide. Alcohol 74% v/v."
},
{
"NDCCode": "80900-000-01",
"PackageDescription": "980 mL in 1 BOTTLE (80900-000-01) ",
"NDC11Code": "80900-0000-01",
"ProductNDC": "80900-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Intertam Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Intertam S.A. de C.V.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N"
},
{
"NDCCode": "65162-358-03",
"PackageDescription": "3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH",
"NDC11Code": "65162-0358-03",
"ProductNDC": "65162-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zafemy",
"NonProprietaryName": "Norelgestromin And Ethinyl Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213950",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "NORELGESTROMIN; ETHINYL ESTRADIOL",
"StrengthNumber": "150; 35",
"StrengthUnit": "ug/d; ug/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "ZAFEMY is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use. ZAFEMY may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. ZAFEMY is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].",
"Description": "ZAFEMY is a transdermal system with a contact surface area of 12.5 cm2. It contains 3.15 mg norelgestromin, USP (NGMN) and 0.289 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN, USP and 35 mcg of EE, USP per day. Systemic exposures (as measured by area under the curve [AUC] and steady-state concentration [Css]) of NGMN, USP and EE, USP during use of ZAFEMY are higher and the Cmax is lower than those produced by an oral contraceptive containing norgestimate, USP (NGM) 250 mcg / EE, USP 35 mcg [see Boxed Warning and Clinical Pharmacology (12.3)]. ZAFEMY is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a tan backing consisting of pigmented polyethylene and polyester. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, polybutene, crospovidone, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN, USP and EE, USP. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a silicone coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Norelgestromin and Ethinyl Estradiol 150/35 mcg per day” in brown ink. The structural formulas of the components are. Norelgestromin, USP ethinyl estradiol, USP. Molecular weight, NGMN, USP: 327.47. Molecular weight, EE, USP: 296.41. Chemical name for NGMN, USP: 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α). Chemical name for EE, USP: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol,(17α)."
},
{
"NDCCode": "65162-469-35",
"PackageDescription": "3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) ",
"NDC11Code": "65162-0469-35",
"ProductNDC": "65162-469",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Eluryng",
"NonProprietaryName": "Etonogestrel And Ethinyl Estradiol",
"DosageFormName": "RING",
"RouteName": "VAGINAL",
"StartMarketingDate": "20191216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210830",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ETONOGESTREL; ETHINYL ESTRADIOL",
"StrengthNumber": ".12; .015",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191216",
"SamplePackage": "N",
"IndicationAndUsage": "FOR VAGINAL USE ONLY. EluRyng is indicated for use by females of reproductive age to prevent pregnancy.",
"Description": "EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent to translucent , colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol, USP (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP over a three-week period of use. EluRyng is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP. EluRyng is not made with natural rubber latex. EluRyng has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol, USP are 324.5 and 296.40, respectively. The structural formulas are as follows."
},
{
"NDCCode": "65162-705-88",
"PackageDescription": "240 mL in 1 BOTTLE (65162-705-88) ",
"NDC11Code": "65162-0705-88",
"ProductNDC": "65162-705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram Oxalate",
"NonProprietaryName": "Escitalopram",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20110903",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202227",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110903",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram oral solution is indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.",
"Description": "Escitalopram oral solution, USP contains escitalopram oxalate USP, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. C2H2O4. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oral solution, USP contains 1.29 mg/mL escitalopram oxalate, USP equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: anhydrous citric acid, glycerin, malic acid, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water, sodium citrate and sorbitol."
},
{
"NDCCode": "65162-791-08",
"PackageDescription": "30 POUCH in 1 CARTON (65162-791-08) / 1 PATCH in 1 POUCH (65162-791-04) ",
"NDC11Code": "65162-0791-08",
"ProductNDC": "65162-791",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200825",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206463",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "700",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200825",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, USP, which is applied to a non-woven polyester backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm × 14 cm. Lidocaine, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine, USP (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyvinyl alcohol, propylparaben, propylene glycol, sodium carboxymethylcellulose, partially neutralized sodium polyacrylate, D-sorbitol, tartaric acid, and urea."
},
{
"NDCCode": "0051-8462-33",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP",
"NDC11Code": "00051-8462-33",
"ProductNDC": "0051-8462",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Androgel",
"NonProprietaryName": "Testosterone",
"DosageFormName": "GEL",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20110429",
"EndMarketingDate": "20250501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022309",
"LabelerName": "AbbVie Inc.",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110429",
"EndMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "AndroGel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .",
"Description": "AndroGel 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1.62% is available in a metered-dose pump or unit dose packets. The active pharmacologic ingredient in AndroGel 1.62% is testosterone. Testosterone USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:. The inactive ingredients in AndroGel 1.62% are: carbopol 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide."
},
{
"NDCCode": "0115-1474-46",
"PackageDescription": "1 TUBE in 1 CARTON (0115-1474-46) > 45 g in 1 TUBE",
"NDC11Code": "00115-1474-46",
"ProductNDC": "0115-1474",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077547",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20060713",
"SamplePackage": "N",
"IndicationAndUsage": "Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.",
"Description": "Metronidazole gel USP (topical), 0.75%, contains metronidazole, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure."
},
{
"NDCCode": "0115-1624-56",
"PackageDescription": "1 TUBE in 1 CARTON (0115-1624-56) > 50 g in 1 TUBE",
"NDC11Code": "00115-1624-56",
"ProductNDC": "0115-1624",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azelaic Acid",
"NonProprietaryName": "Azelaic Acid",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208724",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "AZELAIC ACID",
"StrengthNumber": ".15",
"StrengthUnit": "g/g",
"Pharm_Classes": "Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20181119",
"SamplePackage": "N",
"IndicationAndUsage": "Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of UseAlthough some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.",
"Description": "Azelaic Acid Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C9 H16 O4. It has the following structure. Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol. Azelaic Acid Gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), caprylic/capric triglycerides, carbopol 980, edetate disodium, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH."
},
{
"NDCCode": "0168-0135-15",
"PackageDescription": "15 g in 1 TUBE (0168-0135-15) ",
"NDC11Code": "00168-0135-15",
"ProductNDC": "0168-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19941230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072933",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19941230",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula. Each gram of Fluocinonide Gel USP, 0.05% contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and carbomer 980. Sodium hydroxide solution is added to adjust pH, if required. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "0168-0135-60",
"PackageDescription": "60 g in 1 TUBE (0168-0135-60) ",
"NDC11Code": "00168-0135-60",
"ProductNDC": "0168-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19941230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072933",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19941230",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula. Each gram of Fluocinonide Gel USP, 0.05% contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and carbomer 980. Sodium hydroxide solution is added to adjust pH, if required. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution."
},
{
"NDCCode": "0168-0265-15",
"PackageDescription": "15 g in 1 TUBE (0168-0265-15) ",
"NDC11Code": "00168-0265-15",
"ProductNDC": "0168-0265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "CREAM, AUGMENTED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076215",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20031209",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.",
"Description": "Betamethasone Dipropionate Cream USP 0.05%, (Augmented), contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a white to off-white cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream base of purified water, chlorocresol, white petrolatum, white wax (beeswax), cyclomethicone, sorbitol solution, glyceryl monooleate, propylene glycol, ceteareth-30, carbomer 980, and sodium hydroxide."
},
{
"NDCCode": "0168-0265-50",
"PackageDescription": "50 g in 1 TUBE (0168-0265-50) ",
"NDC11Code": "00168-0265-50",
"ProductNDC": "0168-0265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "CREAM, AUGMENTED",
"RouteName": "TOPICAL",
"StartMarketingDate": "20031209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076215",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20031209",
"SamplePackage": "N",
"IndicationAndUsage": "Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.",
"Description": "Betamethasone Dipropionate Cream USP 0.05%, (Augmented), contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a white to off-white cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream base of purified water, chlorocresol, white petrolatum, white wax (beeswax), cyclomethicone, sorbitol solution, glyceryl monooleate, propylene glycol, ceteareth-30, carbomer 980, and sodium hydroxide."
},
{
"NDCCode": "0168-0288-02",
"PackageDescription": "59 mL in 1 BOTTLE (0168-0288-02) ",
"NDC11Code": "00168-0288-02",
"ProductNDC": "0168-0288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocortisone",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20000725",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040351",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20000725",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone in a vehicle consisting of carbomer 980, propylene glycol, polysorbate 40, propylene glycol stearate, cholesterol and related sterols, isopropyl myristate, sorbitan palmitate, cetyl alcohol, triethanolamine, sorbic acid, simethicone, and purified water. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)- and is represented by the following structural formula:. Hydrocortisone has the molecular formula C21H30O5 and a molecular weight of 362.47. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents."
},
{
"NDCCode": "0168-0407-30",
"PackageDescription": "30 g in 1 TUBE (0168-0407-30)",
"NDC11Code": "00168-0407-30",
"ProductNDC": "0168-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077896",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is."
},
{
"NDCCode": "0168-0407-46",
"PackageDescription": "45 g in 1 TUBE (0168-0407-46)",
"NDC11Code": "00168-0407-46",
"ProductNDC": "0168-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077896",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is."
},
{
"NDCCode": "0168-0407-99",
"PackageDescription": "100 g in 1 TUBE (0168-0407-99)",
"NDC11Code": "00168-0407-99",
"ProductNDC": "0168-0407",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ciclopirox",
"NonProprietaryName": "Ciclopirox",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077896",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CICLOPIROX",
"StrengthNumber": "7.7",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.",
"Description": "Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is."
},
{
"NDCCode": "0168-0457-04",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0457-04) > 120 g in 1 TUBE",
"NDC11Code": "00168-0457-04",
"ProductNDC": "0168-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200735",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP."
},
{
"NDCCode": "0168-0457-30",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0457-30) > 30 g in 1 TUBE",
"NDC11Code": "00168-0457-30",
"ProductNDC": "0168-0457",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200735",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20140714",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .",
"Description": "Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP."
}
]
}
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<NDCList>
<NDC>
<NDCCode>65162-980-29</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (65162-980-29) </PackageDescription>
<NDC11Code>65162-0980-29</NDC11Code>
<ProductNDC>65162-980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207481</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaKeratitisOptic neuritisAllergic conjunctivitisChorioretinitisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisBerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Methylprednisolone tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in ethanol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is (6α, 11β)-11, 17, 21-Trihydroxy-6-methylpregna-1, 4-diene-3, 20-dione and the molecular weight is 374.5 g/mol. The structural formula is represented below. Each methylprednisolone tablet, USP for oral administration contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous lactose, calcium stearate, lactose monohydrate and pregelatinized starch. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>65162-891-29</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (65162-891-29) / 120 SPRAY, METERED in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>65162-0891-29</NDC11Code>
<ProductNDC>65162-891</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mometasone Furoate</ProprietaryName>
<NonProprietaryName>Mometasone</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20170404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207989</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mometasone furoate nasal spray is a corticosteroid indicated for: : 1 Prophylaxis of Nasal Symptoms of Seasonal Allergic Rhinitis in adult and pediatric patients 12 years of age and older (1.1), 2 Treatment of Chronic Rhinosinusitis with Nasal Polyps in adult patients 18 years of age and older (1.2) .</IndicationAndUsage>
<Description>Mometasone furoate anhydrous, USP, the active component of mometasone furoate nasal spray, 50 mcg, is an anti-inflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), and the following chemical structure. Mometasone furoate anhydrous, USP is a white to off-white powder, with an empirical formula of C27H30Cl2O6, and a molecular weight of 521.43 g/mol. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5,000. Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate, USP in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80 and sodium citrate. The pH is between 4.3 and 4.9.</Description>
</NDC>
<NDC>
<NDCCode>65162-982-29</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (65162-982-29) </PackageDescription>
<NDC11Code>65162-0982-29</NDC11Code>
<ProductNDC>65162-982</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207481</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaKeratitisOptic neuritisAllergic conjunctivitisChorioretinitisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisBerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Methylprednisolone tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in ethanol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is (6α, 11β)-11, 17, 21-Trihydroxy-6-methylpregna-1, 4-diene-3, 20-dione and the molecular weight is 374.5 g/mol. The structural formula is represented below. Each methylprednisolone tablet, USP for oral administration contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous lactose, calcium stearate, lactose monohydrate and pregelatinized starch. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>65162-984-29</NDCCode>
<PackageDescription>25 TABLET in 1 BOTTLE (65162-984-29) </PackageDescription>
<NDC11Code>65162-0984-29</NDC11Code>
<ProductNDC>65162-984</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylprednisolone</ProprietaryName>
<NonProprietaryName>Methylprednisolone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207481</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>METHYLPREDNISOLONE</SubstanceName>
<StrengthNumber>32</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methylprednisolone tablets are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisSynovitis of osteoarthritisAcute nonspecific tenosynovitisPost-traumatic osteoarthritisPsoriatic arthritisEpicondylitisAcute gouty arthritis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Severe seborrheic dermatitisExfoliative dermatitisMycosis fungoidesPemphigusSevere psoriasis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:Seasonal or perennial allergic rhinitisDrug hypersensitivity reactionsSerum sicknessContact dermatitisBronchial asthmaAtopic dermatitis. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaKeratitisOptic neuritisAllergic conjunctivitisChorioretinitisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisBerylliosisLoeffler’s syndrome not manageable by other meansFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Methylprednisolone tablets, USP contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder. It is sparingly soluble in ethanol, in dioxane, and in methanol, slightly soluble in acetone, and in chloroform, and very slightly soluble in ether. It is practically insoluble in water. The chemical name for methylprednisolone is (6α, 11β)-11, 17, 21-Trihydroxy-6-methylpregna-1, 4-diene-3, 20-dione and the molecular weight is 374.5 g/mol. The structural formula is represented below. Each methylprednisolone tablet, USP for oral administration contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone, USP. Inactive ingredients: anhydrous lactose, calcium stearate, lactose monohydrate and pregelatinized starch. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.</Description>
</NDC>
<NDC>
<NDCCode>10738-980-23</NDCCode>
<PackageDescription>384.5 mL in 1 BOTTLE (10738-980-23) </PackageDescription>
<NDC11Code>10738-0980-23</NDC11Code>
<ProductNDC>10738-980</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triderma Psoriasis Control</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Genuine Virgin Aloe Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Relieves and helps prevent recurrence of: itching irritation redness flaking scaling due to psoriasis and seborrheic dermatitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10738-980-82</NDCCode>
<PackageDescription>245 mL in 1 BOTTLE, PLASTIC (10738-980-82) </PackageDescription>
<NDC11Code>10738-0980-82</NDC11Code>
<ProductNDC>10738-980</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triderma Psoriasis Control</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Genuine Virgin Aloe Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses Relieves and helps prevent recurrence of: itching irritation redness flaking scaling due to psoriasis and seborrheic dermatitis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41250-980-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (41250-980-10) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>41250-0980-10</NDC11Code>
<ProductNDC>41250-980</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Infants</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100611</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Meijer Distribution Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/.8mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>47335-980-18</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (47335-980-18) </PackageDescription>
<NDC11Code>47335-0980-18</NDC11Code>
<ProductNDC>47335-980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205031</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>47335-980-82</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (47335-980-82) </PackageDescription>
<NDC11Code>47335-0980-82</NDC11Code>
<ProductNDC>47335-980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205031</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>47335-980-86</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (47335-980-86) </PackageDescription>
<NDC11Code>47335-0980-86</NDC11Code>
<ProductNDC>47335-980</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220319</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205031</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide is indicated for: 1 Treatment of partial-onset seizures in patients 1 month of age and older (1.1) , 2 Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, USP, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide, USP is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.29. The chemical structure is:. Lacosamide is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol.</Description>
</NDC>
<NDC>
<NDCCode>58411-980-60</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (58411-980-60) / 21 mL in 1 TUBE</PackageDescription>
<NDC11Code>58411-0980-60</NDC11Code>
<ProductNDC>58411-980</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cle De Peau Beaute Radiant Foundation N M</ProprietaryName>
<ProprietaryNameSuffix>O70</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Shiseido Americas Corporation</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.06; .29</StrengthNumber>
<StrengthUnit>g/21mL; g/21mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70700-112-21</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (70700-112-21) / 88 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>70700-0112-21</NDC11Code>
<ProductNDC>70700-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL, METERED</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210835</ApplicationNumber>
<LabelerName>Xiromed, LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>20.25</StrengthNumber>
<StrengthUnit>mg/1.25g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone gel, 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.</IndicationAndUsage>
<Description>Testosterone gel, 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. Testosterone gel, 1.62% is available in a metered-dose pump. The active pharmacologic ingredient in testosterone gel, 1.62% is testosterone. Testosterone USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is. The inactive ingredients in testosterone gel, 1.62% are: carbopol 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide. Alcohol 74% v/v.</Description>
</NDC>
<NDC>
<NDCCode>80900-000-01</NDCCode>
<PackageDescription>980 mL in 1 BOTTLE (80900-000-01) </PackageDescription>
<NDC11Code>80900-0000-01</NDC11Code>
<ProductNDC>80900-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Intertam Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Intertam S.A. de C.V.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65162-358-03</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH</PackageDescription>
<NDC11Code>65162-0358-03</NDC11Code>
<ProductNDC>65162-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zafemy</ProprietaryName>
<NonProprietaryName>Norelgestromin And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213950</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>NORELGESTROMIN; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>150; 35</StrengthNumber>
<StrengthUnit>ug/d; ug/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZAFEMY is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Limitations of Use. ZAFEMY may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. ZAFEMY is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].</IndicationAndUsage>
<Description>ZAFEMY is a transdermal system with a contact surface area of 12.5 cm2. It contains 3.15 mg norelgestromin, USP (NGMN) and 0.289 mg ethinyl estradiol, USP (EE), and its delivery rate is approximately 150 mcg of NGMN, USP and 35 mcg of EE, USP per day. Systemic exposures (as measured by area under the curve [AUC] and steady-state concentration [Css]) of NGMN, USP and EE, USP during use of ZAFEMY are higher and the Cmax is lower than those produced by an oral contraceptive containing norgestimate, USP (NGM) 250 mcg / EE, USP 35 mcg [see Boxed Warning and Clinical Pharmacology (12.3)]. ZAFEMY is a thin, matrix-type transdermal system consisting of three layers. The backing layer is composed of a tan backing consisting of pigmented polyethylene and polyester. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, polybutene, crospovidone, oleyl alcohol and dipropylene glycol as inactive components. The active components in this layer are the hormones, NGMN, USP and EE, USP. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a silicone coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is printed with “Norelgestromin and Ethinyl Estradiol 150/35 mcg per day” in brown ink. The structural formulas of the components are. Norelgestromin, USP ethinyl estradiol, USP. Molecular weight, NGMN, USP: 327.47. Molecular weight, EE, USP: 296.41. Chemical name for NGMN, USP: 18, 19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17α). Chemical name for EE, USP: 19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol,(17α).</Description>
</NDC>
<NDC>
<NDCCode>65162-469-35</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) </PackageDescription>
<NDC11Code>65162-0469-35</NDC11Code>
<ProductNDC>65162-469</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Eluryng</ProprietaryName>
<NonProprietaryName>Etonogestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>RING</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20191216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210830</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ETONOGESTREL; ETHINYL ESTRADIOL</SubstanceName>
<StrengthNumber>.12; .015</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR VAGINAL USE ONLY. EluRyng is indicated for use by females of reproductive age to prevent pregnancy.</IndicationAndUsage>
<Description>EluRyng (etonogestrel and ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent to translucent , colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol, USP (19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol). When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol, USP over a three-week period of use. EluRyng is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol, USP. EluRyng is not made with natural rubber latex. EluRyng has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. The molecular weights for etonogestrel and ethinyl estradiol, USP are 324.5 and 296.40, respectively. The structural formulas are as follows.</Description>
</NDC>
<NDC>
<NDCCode>65162-705-88</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE (65162-705-88) </PackageDescription>
<NDC11Code>65162-0705-88</NDC11Code>
<ProductNDC>65162-705</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram Oxalate</ProprietaryName>
<NonProprietaryName>Escitalopram</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110903</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202227</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram oral solution is indicated for the treatment of: 1 major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older., 2 generalized anxiety disorder (GAD) in adults.</IndicationAndUsage>
<Description>Escitalopram oral solution, USP contains escitalopram oxalate USP, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate, USP is designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula. C2H2O4. The molecular formula is C20H21FN2O C2H2O4 and the molecular weight is 414.40. Escitalopram oxalate, USP occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane. Escitalopram oral solution, USP contains 1.29 mg/mL escitalopram oxalate, USP equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: anhydrous citric acid, glycerin, malic acid, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water, sodium citrate and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>65162-791-08</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (65162-791-08) / 1 PATCH in 1 POUCH (65162-791-04) </PackageDescription>
<NDC11Code>65162-0791-08</NDC11Code>
<ProductNDC>65162-791</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200825</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206463</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, USP, which is applied to a non-woven polyester backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm × 14 cm. Lidocaine, USP is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine, USP (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyvinyl alcohol, propylparaben, propylene glycol, sodium carboxymethylcellulose, partially neutralized sodium polyacrylate, D-sorbitol, tartaric acid, and urea.</Description>
</NDC>
<NDC>
<NDCCode>0051-8462-33</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00051-8462-33</NDC11Code>
<ProductNDC>0051-8462</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Androgel</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<EndMarketingDate>20250501</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022309</ApplicationNumber>
<LabelerName>AbbVie Inc.</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>16.2</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<EndMarketingDatePackage>20250501</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AndroGel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: : 1 Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. , 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range. .</IndicationAndUsage>
<Description>AndroGel 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1.62% is available in a metered-dose pump or unit dose packets. The active pharmacologic ingredient in AndroGel 1.62% is testosterone. Testosterone USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:. The inactive ingredients in AndroGel 1.62% are: carbopol 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1474-46</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0115-1474-46) > 45 g in 1 TUBE</PackageDescription>
<NDC11Code>00115-1474-46</NDC11Code>
<ProductNDC>0115-1474</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077547</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.</IndicationAndUsage>
<Description>Metronidazole gel USP (topical), 0.75%, contains metronidazole, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure.</Description>
</NDC>
<NDC>
<NDCCode>0115-1624-56</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0115-1624-56) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>00115-1624-56</NDC11Code>
<ProductNDC>0115-1624</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azelaic Acid</ProprietaryName>
<NonProprietaryName>Azelaic Acid</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208724</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>AZELAIC ACID</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of UseAlthough some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.</IndicationAndUsage>
<Description>Azelaic Acid Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C9 H16 O4. It has the following structure. Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol. Azelaic Acid Gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), caprylic/capric triglycerides, carbopol 980, edetate disodium, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0135-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0135-15) </PackageDescription>
<NDC11Code>00168-0135-15</NDC11Code>
<ProductNDC>0168-0135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19941230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072933</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula. Each gram of Fluocinonide Gel USP, 0.05% contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and carbomer 980. Sodium hydroxide solution is added to adjust pH, if required. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>0168-0135-60</NDCCode>
<PackageDescription>60 g in 1 TUBE (0168-0135-60) </PackageDescription>
<NDC11Code>00168-0135-60</NDC11Code>
<ProductNDC>0168-0135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19941230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072933</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula. Each gram of Fluocinonide Gel USP, 0.05% contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and carbomer 980. Sodium hydroxide solution is added to adjust pH, if required. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
<NDC>
<NDCCode>0168-0265-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0265-15) </PackageDescription>
<NDC11Code>00168-0265-15</NDC11Code>
<ProductNDC>0168-0265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM, AUGMENTED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076215</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Cream USP 0.05%, (Augmented), contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a white to off-white cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream base of purified water, chlorocresol, white petrolatum, white wax (beeswax), cyclomethicone, sorbitol solution, glyceryl monooleate, propylene glycol, ceteareth-30, carbomer 980, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0168-0265-50</NDCCode>
<PackageDescription>50 g in 1 TUBE (0168-0265-50) </PackageDescription>
<NDC11Code>00168-0265-50</NDC11Code>
<ProductNDC>0168-0265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM, AUGMENTED</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20031209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076215</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20031209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betamethasone Dipropionate Cream USP, 0.05% (Augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Cream USP 0.05%, (Augmented), contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use in a white to off-white cream base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone. Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula. Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water. Each gram of Betamethasone Dipropionate Cream USP, 0.05% (Augmented), contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a white to off-white cream base of purified water, chlorocresol, white petrolatum, white wax (beeswax), cyclomethicone, sorbitol solution, glyceryl monooleate, propylene glycol, ceteareth-30, carbomer 980, and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>0168-0288-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (0168-0288-02) </PackageDescription>
<NDC11Code>00168-0288-02</NDC11Code>
<ProductNDC>0168-0288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocortisone</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20000725</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040351</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000725</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Each mL of Hydrocortisone Lotion USP, 2.5% contains 25 mg of hydrocortisone in a vehicle consisting of carbomer 980, propylene glycol, polysorbate 40, propylene glycol stearate, cholesterol and related sterols, isopropyl myristate, sorbitan palmitate, cetyl alcohol, triethanolamine, sorbic acid, simethicone, and purified water. Chemically, hydrocortisone is pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)- and is represented by the following structural formula:. Hydrocortisone has the molecular formula C21H30O5 and a molecular weight of 362.47. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.</Description>
</NDC>
<NDC>
<NDCCode>0168-0407-30</NDCCode>
<PackageDescription>30 g in 1 TUBE (0168-0407-30)</PackageDescription>
<NDC11Code>00168-0407-30</NDC11Code>
<ProductNDC>0168-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077896</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0168-0407-46</NDCCode>
<PackageDescription>45 g in 1 TUBE (0168-0407-46)</PackageDescription>
<NDC11Code>00168-0407-46</NDC11Code>
<ProductNDC>0168-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077896</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0168-0407-99</NDCCode>
<PackageDescription>100 g in 1 TUBE (0168-0407-99)</PackageDescription>
<NDC11Code>00168-0407-99</NDC11Code>
<ProductNDC>0168-0407</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ciclopirox</ProprietaryName>
<NonProprietaryName>Ciclopirox</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077896</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CICLOPIROX</SubstanceName>
<StrengthNumber>7.7</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Superficial Dermotophyte Infections - Ciclopirox gel 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum. Seborrheic Dermatitis - Ciclopirox gel 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
<Description>Ciclopirox Gel 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of ciclopirox gel 0.77% contains 7.70 mg of ciclopirox in a gel consisting of purified water, isopropyl alcohol, octyldodecanol, dimethicone copolyol 190, carbomer 980, sodium hydroxide, and docusate sodium. Ciclopirox gel 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0].The chemical structure is.</Description>
</NDC>
<NDC>
<NDCCode>0168-0457-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0457-04) > 120 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0457-04</NDC11Code>
<ProductNDC>0168-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200735</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP.</Description>
</NDC>
<NDC>
<NDCCode>0168-0457-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0457-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0457-30</NDC11Code>
<ProductNDC>0168-0457</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200735</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (1). Limitation of Use: : 1 Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis (1). , 2 Avoid use on the face, groin, or axillae (1.2). , 3 Avoid use in perioral dermatitis or rosacea. .</IndicationAndUsage>
<Description>Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58. It has the following chemical structure:. Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of fluocinonide cream USP, 0.1% contains 1 mg fluocinonide in a cream base of propylene glycol USP, diethylene glycol monoethyl ether NF, glyceryl stearate (and) PEG-100 stearate, purified water USP, glyceryl monostearate NF, white petrolatum USP, carbomer 980 NF, diisopropanolamine, and citric acid USP.</Description>
</NDC>
</NDCList>